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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 215885


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NDA 215885 describes BACLOFEN, which is a drug marketed by Amneal, Heritage, 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 215885
Tradename:BACLOFEN
Applicant:Mankind Pharma
Ingredient:baclofen
Patents:0
Pharmacology for NDA: 215885
Mechanism of ActionGABA A Agonists
GABA B Agonists
Medical Subject Heading (MeSH) Categories for 215885
Suppliers and Packaging for NDA: 215885
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BACLOFEN baclofen TABLET;ORAL 215885 ANDA NCS HealthCare of KY, LLC dba Vangard Labs 0615-8518 0615-8518-05 15 TABLET in 1 BLISTER PACK (0615-8518-05)
BACLOFEN baclofen TABLET;ORAL 215885 ANDA NCS HealthCare of KY, LLC dba Vangard Labs 0615-8518 0615-8518-39 30 TABLET in 1 BLISTER PACK (0615-8518-39)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jan 25, 2022TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jan 25, 2022TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Jan 25, 2022TE:ABRLD:No

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