- No Title 1572550488
- No Title 1572553740
- No Title 1572554173
- Principal Display Panel - 60 Gm Tube Carton
- Permethrin Cream, 5%*
- Description
- Clinical Pharmacology
- Indications And Usage
- Contraindications
- Warnings
- Precautions
- Adverse Reactions
- Overdosage
- Dosage And Administration
- How Supplied
- Storage
- Principal Display Panel - Carton
- No Title 1572453685
- Description
- Clinical Pharmacology
- Indications And Usage
- Contraindications
- Warnings
- Precautions
- Adverse Reactions
- Overdosage
- Dosage And Administration
- How Supplied
- Permethrin
- No Title 1572454309
- Package Label.principal Display Panel
- No Title 1572457338
- Permethrin Cream
No Title 1572550488 ⮝
Rx Only
No Title 1572553740 ⮝
Rx Only
No Title 1572554173 ⮝
Rx Only
Principal Display Panel - 60 Gm Tube Carton ⮝
CommUnity Care Federally Qualified Centers
PERMETHRIN
5% CREAM
60 GMDate:
Name:
Dr.MASSAGE INTO SKIN FROM NECK TO SOLE OF FEET.WASH
OFF IN 8 TO 14 HOURS123456
1/1/01
Permethrin 5% CREAM 60gm NDC 76413-122-60
Batch: 123456
Lot: 123456
Exp: 1/1/01
PERRIGO
Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.
PERMETHRIN
permethrin cream
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76413-122(NDC:45802-269) Route of Administration TOPICAL
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PERMETHRIN (UNII: 509F88P9SZ) (PERMETHRIN - UNII:509F88P9SZ) PERMETHRIN 50 mg in 1 g
Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) LANOLIN ALCOHOLS (UNII: 884C3FA9HE) MINERAL OIL (UNII: T5L8T28FGP) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) CETETH-20 (UNII: I835H2IHHX) FORMALDEHYDE (UNII: 1HG84L3525)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76413-122-60 1 in 1 CARTON 1 60 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076369 08/11/2006
Labeler - Central Texas Community Health Centers (079674019)
Establishment Name Address ID/FEI Business Operations Central Texas Community Health Centers 079674019 REPACK(76413-122) , RELABEL(76413-122) Revised: 1/2016 Document Id: 21659fde-28d9-4457-81dc-fdf007143ae0 Set id: 8e6ee1db-6159-48a5-ba1d-93d148a2ab58 Version: 1 Effective Time: 20160125 Central Texas Community Health Centers
Permethrin Cream, 5%* ⮝
Permethrin Cream, 5%*
*W/W
Rx Only
Description ⮝
Permethrin Cream, 5% is a topical scabicidal agent for the treatment of infestation with Sarcoptes scabiei (scabies). It is available in an off-white, vanishing cream base. Permethrin Cream, 5% is for topical use only.
Chemical Name The permethrin used is an approximate 1:3 mixture of the cis and trans isomers of the pyrethroid 3-(2,2-dichloroethenyl)-2,2-dimethylcyclopropanecarboxylic acid, (3-phenoxyphenyl) methyl ester. Permethrin has a molecular formula of C21H20Cl2O3 and a molecular weight of 391.29. It is a yellow to light orange-brown, low melting solid or viscous liquid.
Active Ingredient Each gram contains permethrin 50 mg (5%).
Inactive Ingredients Butylated hydroxytoluene, carbomer homopolymer type B, fractionated coconut oil, glycerin, glyceryl monostearate, isopropyl myristate, lanolin alcohols, mineral oil, polyoxyethylene cetyl ethers, purified water, and sodium hydroxide. Formaldehyde 1 mg (0.1%) is added as a preservative.
Clinical Pharmacology ⮝
Permethrin, a pyrethroid, is active against a broad range of pests including lice, ticks, fleas, mites, and other arthropods. It acts on the nerve cell membrane to disrupt the sodium channel current by which the polarization of the membrane is regulated. Delayed repolarization and paralysis of the pests are the consequences of this disturbance.
Permethrin is rapidly metabolized by ester hydrolysis to inactive metabolites which are excreted primarily in the urine. Although the amount of permethrin absorbed after a single application of the 5% cream has not been determined precisely, data from studies with 14C-labeled permethrin and absorption studies of the cream applied to patients with moderate to severe scabies indicate it is 2% or less of the amount applied.
Indications And Usage ⮝
Permethrin Cream, 5% is indicated for the treatment of infestation with Sarcoptes scabiei (scabies).
Contraindications ⮝
Permethrin Cream, 5% is contraindicated in patients with known hypersensitivity to any of its components, to any synthetic pyrethroid or pyrethrin.
Warnings ⮝
If hypersensitivity to Permethrin Cream, 5% occurs, discontinue use.
Precautions ⮝
General
Scabies infestation is often accompanied by pruritus, edema, and erythema. Treatment with Permethrin Cream, 5% may temporarily exacerbate these conditions.
Information for Patients
Patients with scabies should be advised that itching, mild burning and/or stinging may occur after application of Permethrin Cream, 5%. In clinical trials, approximately 75% of patients treated with permethrin cream, 5% who continued to manifest pruritus at 2 weeks had cessation by 4 weeks. If irritation persists, they should consult their physician. Permethrin Cream, 5% may be very mildly irritating to the eyes. Patients should be advised to avoid contact with eyes during application and to flush with water immediately if Permethrin Cream, 5% gets in the eyes.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Six carcinogenicity bioassays were evaluated with permethrin, three each in rats and mice. No tumorigenicity was seen in the rat studies. However, species-specific increases in pulmonary adenomas, a common benign tumor of mice of high spontaneous background incidence, were seen in the three mouse studies. In one of these studies there was an increased incidence of pulmonary alveolar-cell carcinomas and benign liver adenomas only in female mice when permethrin was given in their food at a concentration of 5000 ppm. Mutagenicity assays, which give useful correlative data for interpreting results from carcinogenicity bioassays in rodents, were negative. Permethrin showed no evidence of mutagenic potential in a battery of in vitro and in vivo genetic toxicity studies.
Permethrin did not have any adverse effect on reproductive function at a dose of 180 mg/kg/day orally in a three-generation rat study.
Pregnancy
Teratogenic Effects
Pregnancy Category B
Reproduction studies have been performed in mice, rats, and rabbits (200 to 400 mg/kg/day orally) and have revealed no evidence of impaired fertility or harm to the fetus due to permethrin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the evidence for tumorigenic potential of permethrin in animal studies, consideration should be given to discontinuing nursing temporarily or withholding the drug while the mother is nursing.
Pediatric Use
Permethrin Cream, 5% is safe and effective in pediatric patients two months of age and older. Safety and effectiveness in infants less than two months of age have not been established.
Geriatric Use
Clinical studies of permethrin cream, 5% did not identify sufficient numbers of subjects aged 65 and over to allow a definitive statement regarding whether elderly subjects respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. This drug is known to be substantially excreted by the kidney. However, since topical permethrin is metabolized in the liver and excreted in the urine as inactive metabolites, there does not appear to be an increased risk of toxic reactions in patients with impaired renal function when used as labeled.
Adverse Reactions ⮝
In clinical trials, generally mild and transient burning and stinging followed application with permethrin cream, 5% in 10% of patients and was associated with the severity of infestation. Pruritus was reported in 7% of patients at various times post-application. Erythema, numbness, tingling, and rash were reported in 1 to 2% or less of patients (see PRECAUTIONS - General). Other adverse events reported since marketing permethrin cream, 5% include: headache, fever, dizziness, abdominal pain, diarrhea and nausea and/or vomiting. Although extremely uncommon and not expected when used as directed (see DOSAGE AND ADMINISTRATION), rare occurrences of seizure have been reported. None have been medically confirmed as associated with Permethrin Cream, 5% treatment.
Overdosage ⮝
No instance of accidental ingestion of Permethrin Cream, 5% has been reported. If ingested, gastric lavage and general supportive measures should be employed. Excessive topical use (see DOSAGE AND ADMINISTRATION) may result in increased irritation and erythema.
Dosage And Administration ⮝
Adults and children
Thoroughly massage Permethrin Cream, 5% into the skin from the head to the soles of the feet. Scabies rarely infests the scalp of adults, although the hairline, neck, temple, and forehead may be infested in infants and geriatric patients. Usually 30 grams is sufficient for an average adult. The cream should be removed by washing (shower or bath) after 8 to 14 hours. Infants should be treated on the scalp, temple, and forehead. ONE APPLICATION IS GENERALLY CURATIVE.
Patients may experience persistent pruritus after treatment. This is rarely a sign of treatment failure and is not an indication for retreatment. Demonstrable living mites after 14 days indicate that retreatment is necessary.
How Supplied ⮝
Permethrin Cream, 5% (w/w) is available as follows:
60 g tube (NDC 45802-269-37)
Storage ⮝
Store at 20-25 C (68-77 F) [see USP Controlled Room Temperature].
Manufactured by Perrigo
Bronx, NY 10457
Distributed By
PERRIGO
Allegan, MI 49010
Repacked by H.J. Harkins Company, Inc.
Grover Beach, CA 93433
Rev. 2/12
1T600 RC J3
Principal Display Panel - Carton ⮝
Rx Only
Permethrin Cream, 5%*
*w/w
For External Use Only. Not for Use In Eyes.
Permethrin Cream, 5%* Carton
PERMETHRIN
permethrin cream
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52959-159(NDC:45802-269) Route of Administration TOPICAL
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PERMETHRIN (UNII: 509F88P9SZ) (PERMETHRIN - UNII:509F88P9SZ) PERMETHRIN 50 mg in 1 g
Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CARBOMER HOMOPOLYMER TYPE B (UNII: HHT01ZNK31) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) LANOLIN ALCOHOLS (UNII: 884C3FA9HE) MINERAL OIL (UNII: T5L8T28FGP) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) CETETH-20 (UNII: I835H2IHHX) FORMALDEHYDE (UNII: 1HG84L3525)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52959-159-06 1 in 1 CARTON 1 60 g in 1 TUBE
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076369 08/11/2006
Labeler - H.J. Harkins Company, Inc. (147681894)
Registrant - H.J. Harkins Company, Inc. (147681894)
Establishment Name Address ID/FEI Business Operations H.J. Harkins Company, Inc. 147681894 relabel, repack Revised: 2/2012 Document Id: 525aa3b8-7fde-4683-959e-d3da10140cb1 Set id: 0494e7d2-70a5-44e5-a026-559fdf1808dd Version: 1 Effective Time: 20120210 H.J. Harkins Company, Inc.
No Title 1572453685 ⮝
Rx Only
Description ⮝
Permethrin Cream 5% is a topical scabicidal agent for the treatment of infestation with Sarcoptes scabiei (scabies). It is available in a white to off-white, vanishing cream base.
Permethrin cream is for topical use only.
Structural Formula:
Chemical Name: The permethrin used is an approximate 1:3 mixture of the cis and trans isomers of the pyrethroid 3-(2,2-dichloroethenyl)- 2,2-dimethylcyclopropanecarboxylic acid, (3-phenoxyphenyl) methyl ester. Permethrin has a molecular formula of C21H20Cl2O3 and a molecular weight of 391.29. It is a yellow to light orange-brown, low melting solid or viscous liquid.
Each gram contains permethrin 50 mg (5%) and the inactive ingredients butylated hydroxytoluene, carbomer 934P, coconut oil, glycerin, glyceryl stearate, isopropyl myristate, lanolin alcohols, light mineral oil, polyoxyethylene cetyl ethers, purified water, and sodium hydroxide. Formaldehyde 1 mg (0.1%) is added as a preservative.
Clinical Pharmacology ⮝
Permethrin, a pyrethroid, is active against a broad range of pests including lice, ticks, fleas, mites, and other arthropods. It acts on the nerve cell membrane to disrupt the sodium channel current by which the polarization of the membrane is regulated. Delayed repolarization and paralysis of the pests are the consequences of this disturbance.
Permethrin is rapidly metabolized by ester hydrolysis to inactive metabolites which are excreted primarily in the urine. Although the amount of permethrin absorbed after a single application of the 5% cream has not been determined precisely, data from studies with 14C-labeled permethrin and absorption studies of the cream applied to patients with moderate to severe scabies indicate it is 2% or less of the amount applied.
Indications And Usage ⮝
Permethrin cream is indicated for the treatment of infestation with Sarcoptes scabiei (scabies).
Contraindications ⮝
Permethrin cream is contraindicated in patients with known hypersensitivity to any of its components, to any synthetic pyrethroid or pyrethrin.
Warnings ⮝
If hypersensitivity to permethrin cream occurs, discontinue use.
Precautions ⮝
General
Scabies infestation is often accompanied by pruritis, edema and erythema. Treatment with permethrin cream may temporarily exacerbate these conditions.
Information for Patients
Patients with scabies should be advised that itching, mild burning and/or stinging may occur after application of permethrin cream. In clinical trials, approximately 75% of patients treated with permethrin cream who continued to manifest pruritis at 2 weeks had cessation by 4 weeks. If irritation persists, they should consult their physician. Permethrin cream may be very mildly irritating to the eyes. Patients should be advised to avoid contact with eyes during application and to flush with water immediately if permethrin cream gets in the eyes.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Six carcinogenicity bioassays were evaluated with permethrin, three each in rats and mice. No tumorigenicity was seen in the rat studies. However, species-specific increases in pulmonary adenomas, a common benign tumor of mice of high spontaneous background incidence, were seen in the three mouse studies. In one of these studies there was an increased incidence of pulmonary alveolar-cell carcinomas and benign liver adenomas only in female mice when permethrin was given in their food at a concentration of 5000 ppm. Mutagenicity assays, which give useful correlative data for interpreting results from carcinogenicity bioassays in rodents, were negative. Permethrin showed no evidence of mutagenic potential in a battery of in vitro and in vivo genetic toxicity studies.
Permethrin did not have any adverse effect on reproductive function at a dose of 180 mg/kg/day orally in a three-generation rat study.
Pregnancy
Teratogenic Effects
Pregnancy Category B: Reproduction studies have been performed in mice, rats, and rabbits (200 to 400 mg/kg/day orally) and have revealed no evidence of impaired fertility or harm to the fetus due to permethrin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the evidence for tumorigenic potential of permethrin in animal studies, consideration should be given to discontinuing nursing temporarily or withholding the drug while the mother is nursing.
Pediatric Use
Permethrin cream is safe and effective in pediatric patients two months of age and older. Safety and effectiveness in pediatric patients less than two months of age have not been established.
Geriatric Use
Clinical studies of permethrin cream did not identify sufficient numbers of subjects aged 65 and over to allow a definitive statement regarding whether elderly subjects respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. This drug is known to be substantially excreted by the kidney. However, since topical permethrin is metabolized in the liver and excreted in the urine as inactive metabolites, there does not appear to be an increased risk of toxic reactions in patients with impaired renal function when used as labeled.
Adverse Reactions ⮝
In clinical trials, generally mild and transient burning and stinging followed application with permethrin cream in 10% of patients and was associated with the severity of infestation. Pruritis was reported in 7% of patients at various times post-application. Erythema, numbness, tingling, and rash were reported in 1 to 2% or less of patients (see PRECAUTIONS: General).
Overdosage ⮝
No instance of accidental ingestion of permethrin cream has been reported. If ingested, gastric lavage and general supportive measures should be employed.
Dosage And Administration ⮝
Adults and children: Thoroughly massage permethrin cream into the skin from the head to the soles of the feet. Scabies rarely infests the scalp of adults, although the hairline, neck, temple, and forehead may be infested in infants and geriatric patients. Usually 30 grams is sufficient for an average adult. The cream should be removed by washing (shower or bath) after 8 to 14 hours. Infants should be treated on the scalp, temple and forehead. ONE APPLICATION IS GENERALLY CURATIVE.
Patients may experience persistent pruritus after treatment. This is rarely a sign of treatment failure and is not an indication for retreatment. Demonstrable living mites after 14 days indicate that retreatment is necessary.
How Supplied ⮝
Product: 76413-159
NDC: 76413-159-60 60 g in a TUBE
Permethrin ⮝
PERMETHRIN
permethrin cream
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-3149(NDC:45802-269) Route of Administration TOPICAL
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PERMETHRIN (UNII: 509F88P9SZ) (PERMETHRIN - UNII:509F88P9SZ) PERMETHRIN 50 mg in 1 g
Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) LANOLIN ALCOHOLS (UNII: 884C3FA9HE) MINERAL OIL (UNII: T5L8T28FGP) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) CETETH-20 (UNII: I835H2IHHX) FORMALDEHYDE (UNII: 1HG84L3525)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50090-3149-0 1 in 1 CARTON 10/03/2017 1 60 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076369 08/11/2006
Labeler - A-S Medication Solutions (830016429)
Establishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-3149) Revised: 5/2018 Document Id: c5a4b50c-dcaa-488f-a391-d335a5d90d77 Set id: 6296c3d1-8818-4b0d-971f-2eda3379c18e Version: 1 Effective Time: 20180510 A-S Medication Solutions
No Title 1572454309 ⮝
Rx Only
Package Label.principal Display Panel ⮝
Actavis
NDC 0472-0242-60
Permethrin Cream 5% w/w
Rx Only
For External Use Only
Not For Use In Eyes
60g (2.2 oz)
PERMETHRIN
permethrin cream
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0472-0242 Route of Administration TOPICAL
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PERMETHRIN (UNII: 509F88P9SZ) (PERMETHRIN - UNII:509F88P9SZ) PERMETHRIN 50 mg in 1 g
Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CARBOMER 934 (UNII: Z135WT9208) COCONUT OIL (UNII: Q9L0O73W7L) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) LANOLIN ALCOHOLS (UNII: 884C3FA9HE) LIGHT MINERAL OIL (UNII: N6K5787QVP) CETETH-10 (UNII: LF9X1PN3XJ) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) CETETH-20 (UNII: I835H2IHHX) FORMALDEHYDE (UNII: 1HG84L3525)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0472-0242-60 1 in 1 CARTON 11/30/2004 1 60 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074806 11/30/2004
Labeler - Actavis Pharma, Inc. (119723554) Revised: 4/2017 Document Id: c8ba50ed-f063-4668-b880-ce1197032f01 Set id: ad568fc3-8e4a-4cff-9bbb-35312451c43b Version: 6 Effective Time: 20170428 Actavis Pharma, Inc.
No Title 1572457338 ⮝
Rx Only
Permethrin Cream ⮝
PERMETHRIN
permethrin cream
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76413-159(NDC:0472-0242) Route of Administration TOPICAL
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PERMETHRIN (UNII: 509F88P9SZ) (PERMETHRIN - UNII:509F88P9SZ) PERMETHRIN 50 mg in 1 g
Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208) COCONUT OIL (UNII: Q9L0O73W7L) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) LANOLIN ALCOHOLS (UNII: 884C3FA9HE) LIGHT MINERAL OIL (UNII: N6K5787QVP) CETETH-10 (UNII: LF9X1PN3XJ) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) CETETH-20 (UNII: I835H2IHHX) FORMALDEHYDE (UNII: 1HG84L3525)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76413-159-60 60 g in 1 TUBE; Type 0: Not a Combination Product 04/12/2018
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074806 11/30/2004
Labeler - Central Texas Community Health Centers (079674019)
Establishment Name Address ID/FEI Business Operations Travis County Healthcare District 797039398 RELABEL(76413-159) , REPACK(76413-159) Revised: 4/2018 Document Id: 8ade776f-4218-4c21-8652-efa928ac8c30 Set id: d34031b1-0c4e-48e4-8d5c-9c63933c8147 Version: 4 Effective Time: 20180426 Central Texas Community Health Centers
