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Serving leading biopharmaceutical companies globally:

US Department of Justice
US Army
Harvard Business School
Argus Health

Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076132

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NDA 076132 describes RIMANTADINE HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Impax Labs, and Impax Labs Inc, and is included in three NDAs. It is available from five suppliers. Additional details are available on the RIMANTADINE HYDROCHLORIDE profile page.

The generic ingredient in RIMANTADINE HYDROCHLORIDE is rimantadine hydrochloride. There are three drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the rimantadine hydrochloride profile page.
Summary for 076132
Applicant:Impax Labs
Ingredient:rimantadine hydrochloride
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 076132
Mechanism of ActionM2 Protein Inhibitors
Medical Subject Heading (MeSH) Categories for 076132
Suppliers and Packaging for NDA: 076132
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RIMANTADINE HYDROCHLORIDE rimantadine hydrochloride TABLET;ORAL 076132 ANDA Impax Generics 0115-1911 0115-1911-02 500 TABLET, FILM COATED in 1 BOTTLE (0115-1911-02)
RIMANTADINE HYDROCHLORIDE rimantadine hydrochloride TABLET;ORAL 076132 ANDA Impax Generics 0115-1911 0115-1911-01 100 TABLET, FILM COATED in 1 BOTTLE (0115-1911-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Aug 30, 2002TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

US Army
Harvard Business School

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