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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 210315


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NDA 210315 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 210315
Tradename:BACLOFEN
Applicant:Maia Pharms Inc
Ingredient:baclofen
Patents:0
Pharmacology for NDA: 210315
Mechanism of ActionGABA A Agonists
GABA B Agonists
Medical Subject Heading (MeSH) Categories for 210315
Suppliers and Packaging for NDA: 210315
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BACLOFEN baclofen INJECTABLE;INTRATHECAL 210315 ANDA Sagent Pharmaceuticals 25021-680 25021-680-20 1 VIAL in 1 CARTON (25021-680-20) / 20 mL in 1 VIAL
BACLOFEN baclofen INJECTABLE;INTRATHECAL 210315 ANDA MAlA Pharmaceuticals, Inc. 70511-123 70511-123-20 1 VIAL, GLASS in 1 CARTON (70511-123-20) / 20 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRATHECALStrength1MG/ML
Approval Date:Jul 30, 2019TE:APRLD:No

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