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Details for New Drug Application (NDA): 077068

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NDA 077068 describes BACLOFEN, which is a drug marketed by Northstar Hlthcare, Lannett, Mylan, Watson Labs, Ivax Sub Teva Pharms, Mylan Pharms Inc, Teva, Impax Labs, Vintage Pharms, Usl Pharma, Sun Pharm Inds Inc, Caraco, Oxford Pharms, and Sintetica Sa, and is included in twenty-seven NDAs. It is available from forty-two suppliers. Additional details are available on the BACLOFEN profile page.

The generic ingredient in BACLOFEN is baclofen. There are seventeen drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the baclofen profile page.

Summary for NDA: 077068

Vintage Pharms
Therapeutic Class:Antispasticity Agents

Pharmacology for NDA: 077068

Suppliers and Packaging for NDA: 077068

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 077068 ANDA Qualitest Pharmaceuticals 0603-2407 0603-2407-10 10 TABLET in 1 BOTTLE, PLASTIC (0603-2407-10)
TABLET;ORAL 077068 ANDA Qualitest Pharmaceuticals 0603-2407 0603-2407-16 30 TABLET in 1 BOTTLE, PLASTIC (0603-2407-16)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Aug 30, 2005TE:ABRLD:No

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