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Last Updated: April 1, 2026

Details for New Drug Application (NDA): 078401


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NDA 078401 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-two 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 suppliers are listed for this compound. Additional details are available on the baclofen profile page.
Summary for 078401
Tradename:BACLOFEN
Applicant:Northstar Hlthcare
Ingredient:baclofen
Patents:0
Pharmacology for NDA: 078401
Mechanism of ActionGABA A Agonists
GABA B Agonists
Medical Subject Heading (MeSH) Categories for 078401
GABA-B Receptor Agonists
Muscle Relaxants, Central
Suppliers and Packaging for NDA: 078401
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BACLOFEN baclofen TABLET;ORAL 078401 ANDA Northstar RxLLC 16714-071 16714-071-04 100 TABLET in 1 BOTTLE (16714-071-04)
BACLOFEN baclofen TABLET;ORAL 078401 ANDA Northstar RxLLC 16714-071 16714-071-06 1000 TABLET in 1 BOTTLE (16714-071-06)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Sep 18, 2009TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Sep 18, 2009TE:ABRLD:No

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Preferred Citation:

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