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BRIVIACT- brivaracetam tablet, film coatedBRIVIACT- brivaracetam solutionBRIVIACT- brivaracetam injection, suspension


  1. Patient Information
  2. What Is The Most Important Information I Should Know About Briviact?
  3. Call A Healthcare Provider Right Away If You Have Any Of These Symptoms, Especially If They Are New, Worse, Or Worry You:
  4. How Can I Watch For Early Symptoms Of Suicidal Thoughts And Actions?
  5. What Is Briviact?
  6. Who Should Not Take Briviact?
  7. Before Taking Briviact, Tell Your Healthcare Provider About All Of Your Medical Conditions, Including If You:
  8. How Should I Take Briviact?
  9. What Should I Avoid While Taking Briviact?
  10. Briviact May Cause Serious Side Effects, Including:
  11. Active Ingredient:
  12. Tablet Inactive Ingredients:
  13. 10 Mg Tablets:
  14. 25 Mg And 100 Mg Tablets:
  15. 50 Mg Tablets:
  16. 75 Mg Tablets:
  17. Oral Solution Inactive Ingredients:
  18. Revised: 5/2018document Id:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Suicidal Behavior and Ideation

Counsel patients, their caregivers, and/or families that antiepileptic drugs, including BRIVIACT, may increase the risk of suicidal thoughts and behavior, and advise patients to be alert for the emergence or worsening of symptoms of depression; unusual changes in mood or behavior; or suicidal thoughts, behavior, or thoughts about self-harm. Advise patients, their caregivers, and/or families to report behaviors of concern immediately to a healthcare provider[seeWarnings and Precautions (5.1)].

Neurological Adverse Reactions

Counsel patients that BRIVIACT causes somnolence, fatigue, dizziness, and gait disturbance. These adverse reactions, if observed, are more likely to occur early in treatment but can occur at any time. Advise patients not to drive or operate machinery until they have gained sufficient experience on BRIVIACT to gauge whether it adversely affects their ability to drive or operate machinery[seeWarnings and Precautions (5.2)].

Psychiatric Adverse Reactions

Advise patients that BRIVIACT causes changes in behavior (e.g., aggression, agitation, anger, anxiety, and irritability) and psychotic symptoms. Instruct patients to report these symptoms immediately to their healthcare provider[seeWarnings and Precautions (5.3)].

Hypersensitivity: Bronchospasm and Angioedema

Advise patients that symptoms of hypersensitivity including bronchospasm and angioedema can occur with BRIVIACT. Instruct them to seek immediate medical care should they experience signs and symptoms of hypersensitivity[seeWarnings and Precautions (5.4)].

Withdrawal of Antiepileptic Drugs

Advise patients not to discontinue use of BRIVIACT without consulting with their healthcare provider. BRIVIACT should normally be gradually withdrawn to reduce the potential for increased seizure frequency and status epilepticus[seeWarnings and Precautions (5.5)].

Pregnancy

Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during BRIVIACT therapy. Encourage patients to enroll in the North American Antiepileptic Drug Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy[seeUse in Specific Populations (8.1)].

Dosing Instructions

Counsel patients that BRIVIACT may be taken with or without food. Instruct patients that BRIVIACT tablets should be swallowed whole with liquid and not chewed or crushed[seeDosage and Administration (2.2)].

Advise patients that the dosage of BRIVIACT oral solution should be measured using a calibrated measuring device and not a household teaspoon. Instruct patients to discard any unused BRIVIACT oral solution after 5 months of first opening the bottle[seeDosage and Administration (2.2)].

BRIVIACT Tablets, BRIVIACT Oral Solution, and BRIVIACT Injection manufactured for
UCB, Inc.
Smyrna, GA 30080

BRIVIACTis a registered trademark of the UCB Group of Companies.
2018, UCB, Inc., Smyrna, GA 30080
All rights reserved.

What Is The Most Important Information I Should Know About Briviact? 

BRIVIACT is a federally controlled substance (CV) because it can be abused or lead to dependence. Keep BRIVIACT in a safe place to prevent misuse and abuse. Selling or giving away BRIVIACT may harm others and is against the law.

Like other antiepileptic drugs, BRIVIACT may cause suicidal thoughts or actions in a very small number of people, about 1 in 500 people taking it.

Call A Healthcare Provider Right Away If You Have Any Of These Symptoms, Especially If They Are New, Worse, Or Worry You: 

  • thoughts about suicide or dying
  • new or worse depression
  • feeling agitated or restless
  • trouble sleeping (insomnia)
  • acting aggressive, feeling angry, or being violent
  • an extreme increase in activity and talking (mania)
  • attempts to commit suicide
  • new or worse anxiety
  • panic attacks
  • new or worse irritability
  • acting on dangerous impulses
  • other unusual changes in behavior or mood

Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

How Can I Watch For Early Symptoms Of Suicidal Thoughts And Actions? 

  • Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
  • Keep all follow-up visits with your healthcare provider as scheduled.

Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not stop BRIVIACT without first talking to a healthcare provider.

  • Stopping BRIVIACT suddenly can cause serious problems.
  • Stopping a seizure medicine suddenly can cause seizures that will not stop (status epilepticus).

What Is Briviact? 

BRIVIACT is a prescription medicine used to treat partial-onset seizures in people 4 years of age and older.

  • It is not known if BRIVIACT injection is safe for use in children.
  • Children 4 years of age and older should only take BRIVIACT by mouth.
  • BRIVIACT injection is only for use in people 16 years of age and older and may be given in the vein (intravenously) when BRIVIACT is not able to be taken by mouth.

It is not known if BRIVIACT is safe and effective in children younger than 4 years of age.

Who Should Not Take Briviact? 

Do not take BRIVIACT if you are allergic to brivaracetam or any of the inactive ingredients in BRIVIACT.

Before Taking Briviact, Tell Your Healthcare Provider About All Of Your Medical Conditions, Including If You: 

  • have or had depression, mood problems, or suicidal thoughts or behavior.
  • have liver problems.
  • have abused or been dependent on prescription medicines, street drugs, or alcohol.
  • are pregnant or plan to become pregnant. It is not known if BRIVIACT will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking BRIVIACT. You and your healthcare provider will have to decide if you should take BRIVIACT while you are pregnant. If you become pregnant while taking BRIVIACT, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of BRIVIACT and other antiepileptic medicines during pregnancy.
  • are breastfeeding or plan to breastfeed. It is not known if BRIVIACT passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take BRIVIACT.

Tell your healthcare provider about all the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements. BRIVIACT may affect the way other medicines work, and other medicines may affect how BRIVIACT works. Do not start a new medicine without first talking with your healthcare provider. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine.

How Should I Take Briviact? 

  • Take BRIVIACT exactly as your healthcare provider tells you.
  • Your healthcare provider will tell you how much BRIVIACT to take and when to take it.
  • Your healthcare provider may change your dose if needed. Do not change your dose without talking to your healthcare provider.
  • Take BRIVIACT with or without food.
  • Swallow BRIVIACT tablets whole with a liquid. Do not chew or crush BRIVIACT tablets before swallowing.
  • If your healthcare provider has prescribed BRIVIACT oral solution, be sure to ask your pharmacist for a medicine dropper or medicine cup to help you measure the correct amount of BRIVIACT oral solution. Do not use a household teaspoon or tablespoon. Ask your pharmacist for instructions on how to use the measuring device the right way.
  • BRIVIACT injection can be given to you by intravenous (IV) infusion into your vein, as prescribed by your healthcare provider.
  • If you take too much BRIVIACT, call your Poison Control Center or go to the nearest emergency room right away.

What Should I Avoid While Taking Briviact? 

Do not drive or operate machinery until you know how BRIVIACT affects you. BRIVIACT may cause drowsiness, tiredness, dizziness, and problems with your balance and coordination.

Briviact May Cause Serious Side Effects, Including: 

    • Store BRIVIACT at room temperature between 59 F to 86 F (15 C to 30 C).
    • Do not freeze BRIVIACT oral solution.
    • Safely throw away any opened bottle of BRIVIACT oral solution after 5 months of first opening the bottle, even if there is medicine left in the bottle.

    Keep BRIVIACT and all medicines out of the reach of children.

    General information about the safe and effective use of BRIVIACT.

    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use BRIVIACT for a condition for which it was not prescribed. Do not give BRIVIACT to other people, even if they have the same symptoms that you have. It may harm them.

    This Medication Guide summarizes the most important information about BRIVIACT. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about BRIVIACT that is written for health professionals.

Active Ingredient: 

brivaracetam

Tablet Inactive Ingredients: 

croscarmellose sodium, lactose monohydrate, betadex ( -cyclodextrin), anhydrous lactose, and magnesium stearate. The tablet film coating contains the inactive ingredients listed below:

10 Mg Tablets: 

polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide

25 Mg And 100 Mg Tablets: 

polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, black iron oxide

50 Mg Tablets: 

polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, red iron oxide

75 Mg Tablets: 

polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, red iron oxide, black iron oxide

Oral Solution Inactive Ingredients: 

sodium citrate, anhydrous citric acid, methylparaben, sodium carboxymethylcellulose, sucralose, sorbitol solution, glycerin, raspberry flavor, and purified water.

Injection inactive ingredients: sodium acetate (trihydrate), glacial acetic acid, sodium chloride, and water for injection.

Manufactured for UCB, Inc., Smyrna, GA 30080.

BRIVIACTis a registered trademark of the UCB Group of Companies. 2018, UCB, Inc., Smyrna, GA 30080. All rights reserved.

For more information, go to www.BRIVIACT.com or call 1-844-599-2273.

This Medication Guide has been approved by the U.S. Food and Drug Administration
Revised:05/2018

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Carton

NDC 50474-370-66
Rx only

BRIVIACT
(brivaracetam)
tablets

CV

10 mg

ATTENTION PHARMACIST:
Dispense accompanying
medication guide to each patient.

60 tablets

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Carton

PRINCIPAL DISPLAY PANEL - 25 mg Tablet Bottle Carton

NDC 50474-470-66
Rx only

BRIVIACT
(brivaracetam)
tablets

CV

25 mg

ATTENTION PHARMACIST:
Dispense accompanying
medication guide to each patient.

60 tablets

PRINCIPAL DISPLAY PANEL - 25 mg Tablet Bottle Carton

PRINCIPAL DISPLAY PANEL - 50 mg Tablet Bottle Carton

NDC 50474-570-66
Rx only

BRIVIACT
(brivaracetam)
tablets

CV

50 mg

ATTENTION PHARMACIST:
Dispense accompanying
medication guide to each patient.

60 tablets

PRINCIPAL DISPLAY PANEL - 50 mg Tablet Bottle Carton

PRINCIPAL DISPLAY PANEL - 75 mg Tablet Bottle Carton

NDC 50474-670-66
Rx only

BRIVIACT
(brivaracetam)
tablets

CV

75 mg

ATTENTION PHARMACIST:
Dispense accompanying
medication guide to each patient.

60 tablets

PRINCIPAL DISPLAY PANEL - 75 mg Tablet Bottle Carton

PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle Carton

NDC 50474-770-66
Rx only

BRIVIACT
(brivaracetam)
tablets

CV

100 mg

ATTENTION PHARMACIST:
Dispense accompanying
medication guide to each patient.

60 tablets

PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle Carton

PRINCIPAL DISPLAY PANEL - 10 mg/mL Bottle Carton

NDC 50474-870-15
Rx only

BRIVIACT
(brivaracetam)
oral solution
CV

10 mg/mL

ATTENTION PHARMACIST:
Dispense accompanying
medication guide to
each patient

300 mL

PRINCIPAL DISPLAY PANEL - 10 mg/mL Bottle Carton

PRINCIPAL DISPLAY PANEL - 50 mg/5 mL Vial Carton

NDC 50474-970-75
Rx only

BRIVIACT
(brivaracetam) injection
CV

50 mg/5 mL
(10 mg/mL)

For Intravenous Use Only

10 vials

PRINCIPAL DISPLAY PANEL - 50 mg/5 mL Vial Carton
BRIVIACT
brivaracetam tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:50474-370
Route of AdministrationORALDEA ScheduleCV
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
brivaracetam(UNII: U863JGG2IA) (brivaracetam - UNII:U863JGG2IA)brivaracetam10 mg
Inactive Ingredients
Ingredient NameStrength
croscarmellose sodium(UNII: M28OL1HH48)
lactose monohydrate(UNII: EWQ57Q8I5X)
betadex(UNII: JV039JZZ3A)
anhydrous lactose(UNII: 3SY5LH9PMK)
magnesium stearate(UNII: 70097M6I30)
polyvinyl alcohol, unspecified(UNII: 532B59J990)
talc(UNII: 7SEV7J4R1U)
polyethylene glycol 3350(UNII: G2M7P15E5P)
titanium dioxide(UNII: 15FIX9V2JP)
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize7mm
FlavorImprint Codeu10
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50474-370-661 in 1 CARTON05/12/2016
160 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20583605/12/2016
BRIVIACT
brivaracetam tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:50474-470
Route of AdministrationORALDEA ScheduleCV
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
brivaracetam(UNII: U863JGG2IA) (brivaracetam - UNII:U863JGG2IA)brivaracetam25 mg
Inactive Ingredients
Ingredient NameStrength
croscarmellose sodium(UNII: M28OL1HH48)
lactose monohydrate(UNII: EWQ57Q8I5X)
betadex(UNII: JV039JZZ3A)
anhydrous lactose(UNII: 3SY5LH9PMK)
magnesium stearate(UNII: 70097M6I30)
polyvinyl alcohol, unspecified(UNII: 532B59J990)
talc(UNII: 7SEV7J4R1U)
polyethylene glycol 3350(UNII: G2M7P15E5P)
titanium dioxide(UNII: 15FIX9V2JP)
ferric oxide yellow(UNII: EX438O2MRT)
ferrosoferric oxide(UNII: XM0M87F357)
Product Characteristics
ColorGRAYScoreno score
ShapeOVALSize9mm
FlavorImprint Codeu25
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50474-470-661 in 1 CARTON05/12/2016
160 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:50474-470-09100 in 1 CARTON05/12/2016
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:50474-470-141 in 1 CARTON05/12/2016
314 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20583605/12/2016
BRIVIACT
brivaracetam tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:50474-570
Route of AdministrationORALDEA ScheduleCV
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
brivaracetam(UNII: U863JGG2IA) (brivaracetam - UNII:U863JGG2IA)brivaracetam50 mg
Inactive Ingredients
Ingredient NameStrength
croscarmellose sodium(UNII: M28OL1HH48)
lactose monohydrate(UNII: EWQ57Q8I5X)
betadex(UNII: JV039JZZ3A)
anhydrous lactose(UNII: 3SY5LH9PMK)
magnesium stearate(UNII: 70097M6I30)
polyvinyl alcohol, unspecified(UNII: 532B59J990)
talc(UNII: 7SEV7J4R1U)
polyethylene glycol 3350(UNII: G2M7P15E5P)
titanium dioxide(UNII: 15FIX9V2JP)
ferric oxide yellow(UNII: EX438O2MRT)
ferric oxide red(UNII: 1K09F3G675)
Product Characteristics
ColorYELLOWScoreno score
ShapeOVALSize12mm
FlavorImprint Codeu50
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50474-570-661 in 1 CARTON05/12/2016
160 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:50474-570-09100 in 1 CARTON05/12/2016
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:50474-570-141 in 1 CARTON05/12/2016
314 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20583605/12/2016
BRIVIACT
brivaracetam tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:50474-670
Route of AdministrationORALDEA ScheduleCV
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
brivaracetam(UNII: U863JGG2IA) (brivaracetam - UNII:U863JGG2IA)brivaracetam75 mg
Inactive Ingredients
Ingredient NameStrength
croscarmellose sodium(UNII: M28OL1HH48)
lactose monohydrate(UNII: EWQ57Q8I5X)
betadex(UNII: JV039JZZ3A)
anhydrous lactose(UNII: 3SY5LH9PMK)
magnesium stearate(UNII: 70097M6I30)
polyvinyl alcohol, unspecified(UNII: 532B59J990)
talc(UNII: 7SEV7J4R1U)
polyethylene glycol 3350(UNII: G2M7P15E5P)
titanium dioxide(UNII: 15FIX9V2JP)
ferric oxide yellow(UNII: EX438O2MRT)
ferric oxide red(UNII: 1K09F3G675)
ferrosoferric oxide(UNII: XM0M87F357)
Product Characteristics
ColorPURPLEScoreno score
ShapeOVALSize13mm
FlavorImprint Codeu75
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50474-670-661 in 1 CARTON05/12/2016
160 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20583605/12/2016
BRIVIACT
brivaracetam tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:50474-770
Route of AdministrationORALDEA ScheduleCV
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
brivaracetam(UNII: U863JGG2IA) (brivaracetam - UNII:U863JGG2IA)brivaracetam100 mg
Inactive Ingredients
Ingredient NameStrength
croscarmellose sodium(UNII: M28OL1HH48)
lactose monohydrate(UNII: EWQ57Q8I5X)
betadex(UNII: JV039JZZ3A)
anhydrous lactose(UNII: 3SY5LH9PMK)
magnesium stearate(UNII: 70097M6I30)
polyvinyl alcohol, unspecified(UNII: 532B59J990)
talc(UNII: 7SEV7J4R1U)
polyethylene glycol 3350(UNII: G2M7P15E5P)
titanium dioxide(UNII: 15FIX9V2JP)
ferric oxide yellow(UNII: EX438O2MRT)
ferrosoferric oxide(UNII: XM0M87F357)
Product Characteristics
ColorGREEN (green-grey)Scoreno score
ShapeOVALSize15mm
FlavorImprint Codeu100
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50474-770-661 in 1 CARTON05/12/2016
160 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:50474-770-09100 in 1 CARTON05/12/2016
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:50474-770-141 in 1 CARTON05/12/2016
314 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20583605/12/2016
BRIVIACT
brivaracetam solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:50474-870
Route of AdministrationORALDEA ScheduleCV
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
brivaracetam(UNII: U863JGG2IA) (brivaracetam - UNII:U863JGG2IA)brivaracetam10 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
sodium citrate, unspecified form(UNII: 1Q73Q2JULR)
anhydrous citric acid(UNII: XF417D3PSL)
methylparaben(UNII: A2I8C7HI9T)
carboxymethylcellulose sodium, unspecified form(UNII: K679OBS311)
sucralose(UNII: 96K6UQ3ZD4)
sorbitol(UNII: 506T60A25R)
glycerin(UNII: PDC6A3C0OX)
water(UNII: 059QF0KO0R)
Product Characteristics
ColorScore
ShapeSize
FlavorRASPBERRYImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50474-870-151 in 1 CARTON05/12/2016
1300 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20583805/12/2016
BRIVIACT
brivaracetam injection, suspension
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:50474-970
Route of AdministrationINTRAVENOUSDEA ScheduleCV
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
brivaracetam(UNII: U863JGG2IA) (brivaracetam - UNII:U863JGG2IA)brivaracetam50 mg in 5 mL
Inactive Ingredients
Ingredient NameStrength
sodium acetate(UNII: 4550K0SC9B)
acetic acid(UNII: Q40Q9N063P)
sodium chloride(UNII: 451W47IQ8X)
water(UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50474-970-7510 in 1 CARTON05/12/2016
1NDC:50474-970-635 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20583705/12/2016
Labeler -UCB, Inc. (028526403)

Revised: 5/2018document Id: 

c667ad4e-90a2-4338-bf7a-fc911eb7203dSet id: 3cf2f439-0e97-443e-8e33-25ecef616f6cVersion: 12Effective Time: 20180515UCB, Inc.



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