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Details for New Drug Application (NDA): 078401

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NDA 078401 describes BACLOFEN, which is a drug marketed by Northstar Hlthcare, Mylan, Watson Labs, Ivax Sub Teva Pharms, Mylan Pharms Inc, Lannett, Teva, Vintage Pharms, Usl Pharma, Sun Pharm Inds Inc, Impax Labs, Caraco, Oxford Pharms, and Sintetica Sa, and is included in twenty-five NDAs. It is available from forty-five 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-seven suppliers are listed for this compound. Additional details are available on the baclofen profile page.

Summary for NDA: 078401

Therapeutic Class:Antispasticity Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 078401

Suppliers and Packaging for NDA: 078401

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 078401 ANDA Northstar RxLLC 16714-072 16714-072-04 100 TABLET in 1 BOTTLE (16714-072-04)
TABLET;ORAL 078401 ANDA Northstar RxLLC 16714-072 16714-072-05 500 TABLET in 1 BOTTLE (16714-072-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Sep 18, 2009TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Sep 18, 2009TE:ABRLD:No

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.