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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 212067


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NDA 212067 describes BACLOFEN, which is a drug marketed by Amneal, Heritage, Maia Pharms Inc, Pharmobedient, Rubicon Research, Ani Pharms, Andas 5 Holding, Aurobindo Pharma Ltd, Hibrow Hlthcare, Impax, Ivax Sub Teva Pharms, Lannett Co Inc, Mankind Pharma, Micro Labs, Northstar Hlthcare, Oxford Pharms, Ph Health, Regcon Holdings, Rising, Somerset Theraps Llc, Sun Pharm Inds Inc, Teva, Unichem, Usl Pharma, Watson Labs, Yiling, and Zydus Lifesciences, and is included in forty-two NDAs. It is available from fifty-three suppliers. Additional details are available on the BACLOFEN profile page.

The generic ingredient in BACLOFEN is baclofen. There are twenty-one drug master file entries for this compound. Sixty-one suppliers are listed for this compound. Additional details are available on the baclofen profile page.
Summary for 212067
Tradename:BACLOFEN
Applicant:Unichem
Ingredient:baclofen
Patents:0
Pharmacology for NDA: 212067
Mechanism of ActionGABA A Agonists
GABA B Agonists
Medical Subject Heading (MeSH) Categories for 212067
GABA-B Receptor Agonists
Muscle Relaxants, Central
Suppliers and Packaging for NDA: 212067
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BACLOFEN baclofen TABLET;ORAL 212067 ANDA Unichem Pharmaceuticals (USA), Inc. 29300-343 29300-343-01 100 TABLET in 1 BOTTLE (29300-343-01)
BACLOFEN baclofen TABLET;ORAL 212067 ANDA Unichem Pharmaceuticals (USA), Inc. 29300-343 29300-343-05 500 TABLET in 1 BOTTLE (29300-343-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jul 9, 2020TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Jul 9, 2020TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Mar 9, 2023TE:ABRLD:No

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

 
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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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