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GABAZOLPIDEM-5- zolpidem tartrate, choline kit


  1. Patient Information
  2. After Taking Zolpidem Tartrate Tablets, You May Get Up Out Of Bed While Not Being Fully Awake And Do An Activity That You Do Not Know You Are Doing. The Next Morning, You May Not Remember That You Did Anything During The Night. You Have A Higher Chance For Doing These Activities If You Drink Alcohol Or Take Other Medicines That Make You Sleepy With Zolpidem Tartrate Tablets. Reported Activities Include:
  3. Important:
  4. 2. Do Not Take Zolpidem Tartrate Tablets If You:
  5. Zolpidem Tartrate Tablets Are A Sedative-hypnotic (sleep) Medicine. Zolpidem Tartrate Tablets Are Used In Adults For The Short-term Treatment Of A Sleep Problem Called Insomnia. Symptoms Of Insomnia Include:
  6. Who Should Not Take Zolpidem Tartrate Tablets?
  7. Zolpidem Tartrate Tablets May Not Be Right For You. Before Starting Zolpidem Tartrate Tablets, Tell Your Doctor About All Of Your Health Conditions, Including If You:
  8. How Should I Take Zolpidem Tartrate Tablets?
  9. Serious Side Effects Of Zolpidem Tartrate Tablets Include:
  10. The Most Common Side Effects Of Zolpidem Tartrate Tablets Are:
  11. How Should I Store Zolpidem Tartrate Tablets?
  12. What Are The Ingredients In Zolpidem Tartrate Tablets?
  13. Manufactured By:
  14. Usual Adult Dosage:
  15. Exp :
  16. Revised: 8/2011document Id:

Patient Information 

17. PATIENT COUNSELING INFORMATION

Prescribers or other healthcare professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with sedative-hypnotics, should counsel them in its appropriate use, and should instruct them to read the accompanying Medication Guide [seeMedication Guide (17.4)].

17.1 Severe anaphylactoid reactions

Inform patients that severe anaphylactic and anaphylactoid reactions have occurred with zolpidem. Describe the signs/symptoms of these reactions and advise patients to seek medical attention immediately if any of them occur.

17.2 Sleep-driving and other complex behaviors

There have been reports of people getting out of bed after taking a sedative-hypnotic and driving their cars while not fully awake, often with no memory of the event. If a patient experiences such an episode, it should be reported to his or her doctor immediately, since "sleep-driving" can be dangerous. This behavior is more likely to occur when zolpidem tartrate tablets are taken with alcohol or other central nervous system depressants [seeWarnings and Precautions (5.3)]. Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic. As with "sleep-driving", patients usually do not remember these events.

In addition, patients should be advised to report all concomitant medications to the prescriber. Patients should be instructed to report events such as "sleep-driving" and other complex behaviors immediately to the prescriber.

17.3 Administration instructions

Patients should be counseled to take zolpidem tartrate tablets right before they get into bed and only when they are able to stay in bed a full night (7-8 hours) before being active again. Zolpidem tartrate tablets should not be taken with or immediately after a meal. Advise patients NOT to take zolpidem tartrate tablets when drinking alcohol.

17.4 Medication Guide

Read the Medication Guide that comes with zolpidem tartrate tablets before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment.

After Taking Zolpidem Tartrate Tablets, You May Get Up Out Of Bed While Not Being Fully Awake And Do An Activity That You Do Not Know You Are Doing. The Next Morning, You May Not Remember That You Did Anything During The Night. You Have A Higher Chance For Doing These Activities If You Drink Alcohol Or Take Other Medicines That Make You Sleepy With Zolpidem Tartrate Tablets. Reported Activities Include: 


driving a car ("sleep-driving")
making and eating food
talking on the phone
having sex
sleep-walking

Call your doctor right away if you find out that you have done any of the above activities after taking zolpidem tartrate tablets.

Important: 


1. Take zolpidem tartrate tablets exactly as prescribed

Do not take more zolpidem tartrate tablets than prescribed.
Take zolpidem tartrate tablets right before you get in bed, not sooner.

2. Do Not Take Zolpidem Tartrate Tablets If You: 


drink alcohol
take other medicines that can make you sleepy. Talk to your doctor about all of your medicines. Your doctor will tell you if you can take zolpidem tartrate tablets with your other medicines.
cannot get a full night s sleep

Zolpidem Tartrate Tablets Are A Sedative-hypnotic (sleep) Medicine. Zolpidem Tartrate Tablets Are Used In Adults For The Short-term Treatment Of A Sleep Problem Called Insomnia. Symptoms Of Insomnia Include: 


trouble falling asleep

Zolpidem tartrate tablets are not for children.

Zolpidem tartrate is a federally controlled substance (C-IV)
because it can be abused or lead to dependence. Keep
zolpidem tartrate tablets in a safe place to prevent misuse
and abuse. Selling or giving away zolpidem tartrate tablets
may harm others, and is against the law. Tell your doctor if
you have ever abused or have been dependent on alcohol,
prescription medicines or street drugs.

Who Should Not Take Zolpidem Tartrate Tablets? 


Do not take zolpidem tartrate tablets if you are allergic to anything in it.

See the end of this Medication Guide for a complete list of ingredients in zolpidem tartrate tablets.

Zolpidem Tartrate Tablets May Not Be Right For You. Before Starting Zolpidem Tartrate Tablets, Tell Your Doctor About All Of Your Health Conditions, Including If You: 


have a history of depression, mental illness, or suicidal thoughts
have a history of drug or alcohol abuse or addiction
have kidney or liver disease
have a lung disease or breathing problems
are pregnant, planning to become pregnant, or breastfeeding

Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Medicines can interact with each other, sometimes causing serious side effects. Do not take zolpidem tartrate tablets with other medicines that can make you sleepy.

Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.

How Should I Take Zolpidem Tartrate Tablets? 


Take zolpidem tartrate tablets exactly as prescribed. Do not take more zolpidem tartrate tablets than prescribed for you.
Take zolpidem tartrate tablets right before you get into bed.
Do not take zolpidem tartrate tablets unless you are able to stay in bed a full night (7-8 hours) before you must be active again.
For faster sleep onset, zolpidem tartrate tablets should NOT be taken with or immediately after a meal.
Call your doctor if your insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problem.
If you take too much zolpidem tartrate tablets or overdose, call your doctor or poison control center right away, or get emergency treatment.

Serious Side Effects Of Zolpidem Tartrate Tablets Include: 


getting out of bed while not being fully awake and do an activity that you do not know you are doing. (See "What is the most important information I should know about zolpidem tartrate tablets?)
abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, and suicidal thoughts or actions.
memory loss
anxiety
severe allergic reactions. Symptoms include swelling of the tongue or throat, trouble breathing, and nausea and vomiting. Get emergency medical help if you get these symptoms after taking zolpidem tartrate tablets.

Call your doctor right away if you have any of the above side effects or any other side effects that worry you while using zolpidem tartrate tablets.

The Most Common Side Effects Of Zolpidem Tartrate Tablets Are: 


drowsiness
dizziness
diarrhea
"drugged feelings"
You may still feel drowsy the next day after taking zolpidem tartrate tablets. Do not drive or do other dangerous activities after taking zolpidem tartrate tablets until you feel fully awake.

After you stop taking a sleep medicine, you may have symptoms for 1 to 2 days such as: trouble sleeping, nausea, flushing, lightheadedness, uncontrolled crying, vomiting, stomach cramps, panic attack, nervousness, and stomach area pain.

These are not all the side effects of zolpidem tartrate tablets. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1 800 FDA 1088.

How Should I Store Zolpidem Tartrate Tablets? 


Store at 20 -25 C (68 -77 F); excursions permitted to 15 - 30 C (59 - 86 F) [see USP Controlled Room Temperature].
Keep zolpidem tartrate tablets and all medicines out of reach of children.

General Information about zolpidem tartrate tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
Do not use zolpidem tartrate tablets for a condition for which it was not prescribed.
Do not share zolpidem tartrate tablets with other people, even if you think they have the same symptoms that you have. It may harm them and it is against the law.

This Medication Guide summarizes the most important information about zolpidem tartrate tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about zolpidem tartrate tablets that is written for healthcare professionals. For more information about zolpidem tartrate tablets, call 1-269-544-2299.

What Are The Ingredients In Zolpidem Tartrate Tablets? 


Active Ingredient: Zolpidem tartrate

Inactive Ingredients: hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, polyethylene glycol, sodium starch glycolate, titanium dioxide and ferric oxide red; the 10 mg tablet also contains ferric oxide yellow.

Rx Only

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Torrent

Manufactured By: 


TORRENT PHARMACEUTICALS LTD., Indrad-382 721, Dist. Mehsana, INDIA.

For:

TORRENT PHARMA INC., 5380 Holiday Terrace, Suite 40,

Kalamazoo, Michigan 49009.

8023534

500 Tablets NDC 13668-007-05

Zolpidem Tartrate Tablets IV

5 mg

PHARMACIST: Dispense the Medication Guide provided separately to each patient.

Each tablet contains 5 mg of zolpidem tartrate. Rx only

Store at 20 -25 C (68 -77 F); excursions permitted to 15 - 30 C (59 - 86 F) [see USP Controlled Room Temperature].

Dispense in a tight, light-resistant, child-resistant container.

Usual Adult Dosage: 

See accompanying prescribing information.

Torrent Mfg. Lic. No. : G/926

Exp : 


8021719

GABAdone (US patent pending) capsules by oral administration. A specially formulated Medical Food product, consisting of a proprietary blend of amino acids and polyphenol ingredients in specific proportions, for the dietary management of the metabolic processes of sleep disorders (SD).
Must be administered under physician supervision.

Medical Foods
Medical Food products are often used in hospitals (e.g., for burn victims or kidney dialysis patients) and outside of a hospital setting under a physician s care for the dietary management of diseases in patients with particular medical or metabolic needs due to their disease or condition. Congress defined "Medical Food" in the Orphan Drug Act and Amendments of 1988 as "a system which is formulated to be consumed or administered enterally [or orally] under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation." Medical Foods are complex formulated products, requiring sophisticated and exacting technology. GABAdone has been developed, manufactured, and labeled in accordance with both the statutory and the FDA regulatory definition of a Medical Food. GABAdone must be used while the patient is under the ongoing care of a physician.

SLEEP DISORDERS (SD)

SD as a Metabolic Deficiency Disease
A critical component of the definition of a Medical Food is the requirement for a distinctive nutritional deficiency. FDA scientists have proposed a physiologic definition of a distinctive nutritional deficiency as follows: the dietary management of patients with specific diseases requires, in some instances, the ability to meet nutritional requirements that differ substantially from the needs of healthy persons. For example, in establishing the recommended dietary allowances for general, healthy population, the Food and Nutrition Board of the Institute of Medicine National Academy of Sciences, recognized that different or distinctive physiologic requirements may exist for certain persons with "special nutritional needs arising from metabolic disorders, chronic diseases, injuries, premature birth, other medical conditions and drug therapies. Thus, the distinctive nutritional needs associated with a disease reflect the total amount needed by a healthy person to support life or maintain homeostasis, adjusted for the distinctive changes in the nutritional needs of the patient as a result of the effects of the disease process on absorption, metabolism, and excretion. It was also proposed that in patients with certain disease states who respond to nutritional therapies, a physiologic deficiency of the nutrient is assumed to exist. For example, if a patient with sleep disorders responds to a tryptophan formulation by improving the duration and quality of sleep, a deficiency of tryptophan is assumed to exist.

Patients with sleep disorders are known to have nutritional deficiencies of tryptophan, choline, flavonoids, and certain antioxidants. Patients with sleep disorders frequently exhibit reduced plasma levels of tryptophan and have been shown to respond to oral administration of tryptophan or a 5-hydoxytryptophan formulation. Research has shown that tryptophan reduced diets result in a fall in circulating tryptophan. Patients with sleep disorders frequently experience activation of the tryptophan degradation pathway that increases the turnover of tryptophan leading to a reduced level of production of serotonin for a given tryptophan blood level. Research has also shown that a genetic predisposition to accelerated tryptophan degradation can lead to increased tryptophan requirements in certain patients with sleep disorders.

Choline is required to fully potentiate acetylcholine synthesis by brain neurons. A deficiency of choline leads to reduced acetylcholine production by the neurons. Low fat diets, frequently used by patients with sleep disorders, are usually choline deficient. Flavonoids potentiate the production of acetylcholine by the neurons thereby inducing REM sleep. Low fat diets and diets deficient in flavonoid rich foods result in inadequate flavonoid concentrations, impeding acetylcholine production in certain patients with sleep disorders. Provision of tryptophan, choline, and flavonoids with antioxidants, in specific proportions can restore the production of beneficial serotonin and acetylcholine, thereby improving sleep quality.

PRODUCT DESCRIPTION

Primary Ingredients
GABAdone consists of a proprietary blend of amino acids, cocoa, ginkgo biloba and flavonoids in specific proportions. These ingredients fall into the category of Generally Regarded as Safe (GRAS) as defined by the Food and Drug Administration (FDA) (Sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act). A GRAS substance is distinguished from a food additive on the basis of the common knowledge about the safety of the substance for its intended use. The standard for an ingredient to achieve GRAS status requires not only technical demonstration of non-toxicity and safety, but also general recognition of safety through widespread usage and agreement of that safety by experts in the field. Many ingredients have been determined by the U.S. Food and Drug Administration (FDA) to be GRAS, and are listed as such by regulation, in Volume 21 Code of Federal Regulations (CFR) Sections 182, 184, and 186.

Amino Acids
Amino Acids are the building blocks of protein. All amino acids are GRAS listed as they have been ingested by humans for thousands of years. The doses of the amino acids in GABAdone are equivalent to those found in the usual human diet; however the formulation uses specific ratios of the key ingredients to elicit a therapeutic response. Tryptophan, for example, is an obligatory amino acid. The body cannot make tryptophan and must obtain tryptophan from the diet. Tryptophan is needed to produce serotonin. Serotonin is required to induce sleep. Patients with sleep disorders have altered serotonin metabolism. Some patients with sleep disorders have a resistance to the use of tryptophan that is similar to the mechanism found in insulin resistance. Patients with sleep disorders cannot acquire sufficient tryptophan from the diet to establish normal sleep architecture without ingesting a prohibitively large amount of calories, particularly calories from protein.

Flavonoids
Flavonoids are a group of phytochemical compounds found in all vascular plants including fruits and vegetables. They are a part of a larger class of compounds known as polyphenols. Many of the therapeutic or health benefits of colored fruits and vegetables, cocoa, red wine, and green tea are directly related to their flavonoid content. The amounts of specially formulated flavonoids found in GABAdone cannot be obtained from conventional foods in the necessary proportions to elicit a therapeutic response.

Physical Description
GABAdone is a yellow to light brown powder. GABAdone contains L-Glutamic Acid, 5-Hydroxytryptophan as Griffonia Seed Extract, Acetyl L-Carnitine HCL, Gamma Amino Butyric Acid, Choline Bitartrate, Hydrolyzed Whey Protein, Cocoa, Ginkgo Biloba, Valerian Root, and Grape Seed Extract.

Other Ingredients
GABAdone contains the following inactive or other ingredients, as fillers, excipients, and colorings: magnesium stearate, microcrystalline cellulose, Maltodextrin NF, gelatin (as the capsule material).

CLINICAL PHARMACOLOGY

Mechanism of Action
GABAdone acts by restoring and maintaining the balance of the neurotransmitters, serotonin, and acetylcholine that are required for maintaining normal sleep architecture. A deficiency of these neurotransmitters is associated with sleep disorders.

Metabolism
The amino acids in GABAdone are primarily absorbed by the stomach and small intestines. All cells metabolize the amino acids in GABAdone. Circulating tryptophan and choline blood levels determine the production of serotonin and acetylcholine.

Excretion
GABAdone is not an inhibitor of cytochrome P450 1A2, 2C9, 2C19, 2D6, or 3A4. These isoenzymes are principally responsible for 95% of all detoxification of drugs, with CYP3A4 being responsible for detoxification of roughly 50% of drugs. Amino acids do not appear to have an effect on drug metabolizing enzymes.

INDICATIONS FOR USE
GABAdone is intended for the clinical dietary management of the metabolic processes in patients with sleep disorders and sleep disorders associated with anxiety.

- Insomnia
- Sleep maintenance insomnia
- Sleep disorders of circadian origin
- Sleep disorders associated with anxiety
- Snoring

CLINICAL EXPERIENCE
Patients taking GABAdone have demonstrated significant functional improvements when this therapeutic agent is used for the dietary management of the metabolic processes associated with sleep disorders. The administration of GABAdone results in the induction and maintenance of sleep in patients with sleep disorders. GABAdone has no effect on normal blood pressure.

PRECAUTIONS AND CONTRAINDICATIONS
GABAdone is contraindicated in an extremely small number of patients with hypersensitivity to any of the nutritional components of GABAdone.

ADVERSE REACTIONS
Oral supplementation with L-tryptophan or choline at high doses up to 15 grams daily is generally well tolerated. The most common adverse reactions of higher doses from 15 to 30 grams daily are nausea, abdominal cramps, and diarrhea. Some patients may experience these symptoms at lower doses. The total combined amount of amino acids in each GABAdone capsule does not exceed 400 mg.

DRUG INTERACTIONS
GABAdone does not directly influence the pharmacokinetics of prescription drugs. Clinical experience has shown that administration of GABAdone may allow for lowering the dose of co-administered drugs under physician supervision.

OVERDOSE
There is a negligible risk of overdose with GABAdone as the total dosage of amino acids in a one month supply (60 capsules) is less than 25 grams. Overdose symptoms may include diarrhea, weakness, and nausea.

POST-MARKETING SURVEILLANCE
Post-marketing surveillance has shown no serious adverse reactions. Reported cases of mild rash and itching may have been associated with allergies to GABAdone flavonoid ingredients, including cinnamon, cocoa, and chocolate. The reactions were transient in nature and subsided within 24 hours.

DOSAGE AND ADMINISTRATION
Recommended Administration
For the dietary management of the metabolic processes in patients with sleep disorders. Take (2) capsules daily at bedtime. An additional dose of one or two capsules may be taken after awakenings during the night. As with most amino acid formulations GABAdone should be taken without food to increase the absorption of key ingredients.

How Supplied
GABAdone is supplied in blue and white, size 0 capsules in bottles of 60 capsules.

Physician Supervision
GABAdone is a Medical Food product available by prescription only and must be used while the patient is under ongoing physician supervision.

U.S. patent pending.

Manufactured by Arizona Nutritional Supplements, Inc. Chandler AZ 85225

Distributed by Physician Therapeutics LLC, Los Angeles, CA 90077. www.ptlcentral.com

Copyright 2003-2006, Physician Therapeutics LLC, all rights reserved

NDC # 68405-1004-02

Storage
Store at room temperature, 59-86OF (15-30OC) Protect from light and moisture. GABAdone is supplied to physicians in a recyclable plastic bottle with a child-resistant cap.

Directions for use: Must be administered under physician supervision. For adults only. As a Medical Food, take one (1) or two (2) capsules daily at bedtime or as directed by physician. Fot the dietary management of sleep disorders. Contains no added sugar, starch, wheat, yeast, preservatives, artificial flavor. Storage: Keep tightly closed in a cool dry place 8-32 degree centigrade (45-90 degree F), relative humidity, below 50%. Warning: Keep this product out of the reach of children. NDC# 68405-1004-02 PHYSICIAN THERAPEUTICS GABADONE Medical Food Rx only 60 Capsules Ingredients: Each serving (per 2 capsules) contains: Proprietary Amino Acid Blend Choline Bitartrate, Gamma Amino Butyric Acid (GABA), Glutamic Acid (L-Glutamic Acid), Whey Protein Hydrolysate 80%, Griffonia Seed Extract (5-HTP), Cocoa Extract (fruit), Proprietary Herbal Blend Indian Valerian Extract 4:1 (root), Ginkgo Biloba (leaves), Acetyl L-Carnitine HCI, Grape Extract (95% Polyphenols) (seed) Other IngredientsL Gelatin, tricalcium phosphate, silicon dioxide, vegetable magnesium stearate, FDandC blue #1, titanium dioxide. Distributed exclusively by: Physicians Therapeutics LLC A Divisions of Targeted Medical Pharma, Inc. Los Angeles, CA 90077 www.ptlcentral.com Patent Pending 68405-1004-02

68405-023-26 For the Dietary Management of Sleep Disorders Associated with Depression.. Two capsules at bedtime or as directed by physician. See product label and insert. Sentra PM Medical Food PHYSICIAN THERAPEUTICS Sentra PM + Zolpidem 5 mg A Convenience Packed Medical Food and Drug Sentrazolpidem PM-5 PHYSICIAN THERAPEUTICS - Sentra PM 60 Capsules - Zolpidem 5 mg 30 Tablets Rx Only No Refills Without Physician Authorization NDC# 68405-023-26 of this co-pack As prescribed by physician. See product label and product information insert. Zolpidem 5 mg Rx Drug Manufactured and Distributed by Physician Therapeutics, A Division of Targeted Medical Pharma Inc. Los Angeles, CA 90077 www.ptlcentral. B-NDC# 68405-8023-26


GabaDone Label

ZolpidemLabel

Gabazolpidem-5

GABAZOLPIDEM-5
zolpidem tartrate, choline kit
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68405-044
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68405-044-261 in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE30
Part 21 BOTTLE60
Part 1 of 2
ZOLPIDEM TARTRATE
zolpidem tartrate tablet
Product Information
Item Code (Source)NDC:52959-879(NDC:13668-007)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZOLPIDEM TARTRATE(UNII: WY6W63843K) (ZOLPIDEM - UNII:7K383OQI23)ZOLPIDEM TARTRATE5 mg
Product Characteristics
Colorred (RED)Scoreno score
ShapeCAPSULESize10mm
FlavorImprint Code5MG
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52959-879-3030 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07790307/07/2011
Part 2 of 2
GABADONE
choline capsule
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHOLINE(UNII: N91BDP6H0X) (CHOLINE - UNII:N91BDP6H0X)CHOLINE125 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
GELATIN(UNII: 2G86QN327L)
Product Characteristics
Colorblue (BLUE WHITE)Scoreno score
ShapeCAPSULESize21mm
FlavorImprint Code;
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
160 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Medical Food07/07/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/07/2011
Labeler -Physician Therapeutics LLC (931940964)
Establishment
NameAddressID/FEIBusiness Operations
Torrent Pharmaceuticals Limited916488547manufacture
Establishment
NameAddressID/FEIBusiness Operations
H.J. Harkins Company, Inc147681894repack
Establishment
NameAddressID/FEIBusiness Operations
Targeted Medical Pharma Inc.126962740manufacture

Revised: 8/2011document Id: 

74ee69ec-2e92-4874-9292-c4a226b15402Set id: d31076b4-44ac-4f8b-8df6-5200cdbea12bVersion: 7Effective Time: 20110801Physician Therapeutics LLC



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