You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

Details for New Drug Application (NDA): 077971


✉ Email this page to a colleague

« Back to Dashboard


NDA 077971 describes BACLOFEN, which is a drug marketed by Acic Pharms, Amneal, Maia Pharms Inc, Mylan Labs Ltd, Rubicon, Ani Pharms, Appco, Aurobindo Pharma Ltd, Beximco Pharms Usa, Eywa Pharma, Graviti Pharms, Impax, Innogenix, Ivax Sub Teva Pharms, Lannett Co Inc, Mankind Pharma, Micro Labs, Mylan, Northstar Hlthcare, Oxford Pharms, Rising, Sun Pharm Inds Inc, Teva, Unichem, Upsher Smith Labs, Usl Pharma, Vintage Pharms, Watson Labs, and Zydus, and is included in forty-one NDAs. It is available from fifty-one 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-one suppliers are listed for this compound. Additional details are available on the baclofen profile page.
Summary for 077971
Tradename:BACLOFEN
Applicant:Impax
Ingredient:baclofen
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077971
Mechanism of ActionGABA A Agonists
GABA B Agonists
Medical Subject Heading (MeSH) Categories for 077971
Suppliers and Packaging for NDA: 077971
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BACLOFEN baclofen TABLET;ORAL 077971 ANDA Amneal Pharmaceuticals of New York LLC 0115-1010 0115-1010-01 100 TABLET in 1 BOTTLE (0115-1010-01)
BACLOFEN baclofen TABLET;ORAL 077971 ANDA Amneal Pharmaceuticals of New York LLC 0115-1010 0115-1010-02 500 TABLET in 1 BOTTLE (0115-1010-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Oct 26, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Oct 26, 2007TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jul 7, 2021TE:ABRLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.