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Generated: April 19, 2019

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Details for New Drug Application (NDA): 019649

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NDA 019649 describes FLUMADINE, which is a drug marketed by Forest Labs and Sun Pharm Inds Inc and is included in two NDAs. It is available from one supplier. Additional details are available on the FLUMADINE profile page.

The generic ingredient in FLUMADINE is rimantadine hydrochloride. There are three drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the rimantadine hydrochloride profile page.
Summary for 019649
Applicant:Sun Pharm Inds Inc
Ingredient:rimantadine hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 019649
Mechanism of ActionM2 Protein Inhibitors
Medical Subject Heading (MeSH) Categories for 019649
Suppliers and Packaging for NDA: 019649
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUMADINE rimantadine hydrochloride TABLET;ORAL 019649 NDA Caraco Pharma, Inc. 49708-521 49708-521-88 100 TABLET in 1 BOTTLE (49708-521-88)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Sep 17, 1993TE:ABRLD:Yes

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