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Generated: December 18, 2018

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Details for New Drug Application (NDA): 072824

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NDA 072824 describes BACLOFEN, which is a drug marketed by Emerald Intl Ltd, Mylan Labs Ltd, Impax Labs, Ivax Sub Teva Pharms, Lannett Co Inc, Mylan, Mylan Pharms Inc, Northstar Hlthcare, Oxford Pharms, Rubicon Res Pvt Ltd, Sun Pharm Inds Inc, Teva, Usl Pharma, Vintage Pharms, and Watson Labs, and is included in twenty-five NDAs. It is available from thirty-eight suppliers. Additional details are available on the BACLOFEN profile page.

The generic ingredient in BACLOFEN is baclofen. There are nineteen drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the baclofen profile page.
Summary for 072824
Tradename:BACLOFEN
Applicant:Watson Labs
Ingredient:baclofen
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 072824
Medical Subject Heading (MeSH) Categories for 072824
Suppliers and Packaging for NDA: 072824
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BACLOFEN baclofen TABLET;ORAL 072824 ANDA Rebel Distributors Corp. 21695-014 21695-014-42 42 BOTTLE in 1 BOTTLE (21695-014-42) > 30 TABLET in 1 BOTTLE (21695-014-30)
BACLOFEN baclofen TABLET;ORAL 072824 ANDA Rebel Distributors Corp. 21695-014 21695-014-72 120 TABLET in 1 BOTTLE (21695-014-72)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG
Approval Date:Sep 18, 1991TE:RLD:No

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