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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 072234


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NDA 072234 describes BACLOFEN, which is a drug marketed by Acic Pharms, Amneal, Maia Pharms Inc, Mylan Labs Ltd, Rubicon, Ani Pharms, Andas 5 Holding, Appco, Aurobindo Pharma Ltd, Beximco Pharms Usa, Endo Operations, Eywa, Graviti Pharms, Impax, Ivax Sub Teva Pharms, Lannett Co Inc, Mankind Pharma, Micro Labs, Northstar Hlthcare, Norvium Bioscience, Oxford Pharms, Rising, Sun Pharm Inds Inc, Teva, Unichem, Upsher Smith Labs, Usl Pharma, Watson Labs, and Zydus Lifesciences, and is included in forty-one NDAs. It is available from fifty-five 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-five suppliers are listed for this compound. Additional details are available on the baclofen profile page.
Summary for 072234
Tradename:BACLOFEN
Applicant:Ivax Sub Teva Pharms
Ingredient:baclofen
Patents:0
Pharmacology for NDA: 072234
Mechanism of ActionGABA A Agonists
GABA B Agonists
Medical Subject Heading (MeSH) Categories for 072234
Suppliers and Packaging for NDA: 072234
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BACLOFEN baclofen TABLET;ORAL 072234 ANDA Teva Pharmaceuticals USA, Inc. 0172-4096 0172-4096-60 100 TABLET in 1 BOTTLE (0172-4096-60)
BACLOFEN baclofen TABLET;ORAL 072234 ANDA Teva Pharmaceuticals USA, Inc. 0172-4096 0172-4096-80 1000 TABLET in 1 BOTTLE (0172-4096-80)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jul 21, 1988TE:ABRLD:No

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