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Last Updated: April 19, 2024

RIMANTADINE HYDROCHLORIDE - Generic Drug Details


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What are the generic sources for rimantadine hydrochloride and what is the scope of freedom to operate?

Rimantadine hydrochloride is the generic ingredient in two branded drugs marketed by Forest Labs, Sun Pharm Inds Inc, Chartwell Rx, Impax Labs, and Impax Labs Inc, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for rimantadine hydrochloride. One supplier is listed for this compound.

Summary for RIMANTADINE HYDROCHLORIDE
Recent Clinical Trials for RIMANTADINE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of OxfordPhase 2/Phase 3
The Leeds Teaching Hospitals NHS Trust
Cancer Research UK

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Pharmacology for RIMANTADINE HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for RIMANTADINE HYDROCHLORIDE

US Patents and Regulatory Information for RIMANTADINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Impax Labs Inc RIMANTADINE HYDROCHLORIDE rimantadine hydrochloride TABLET;ORAL 075916-001 Nov 2, 2001 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Forest Labs FLUMADINE rimantadine hydrochloride SYRUP;ORAL 019650-001 Sep 17, 1993 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Chartwell Rx RIMANTADINE HYDROCHLORIDE rimantadine hydrochloride TABLET;ORAL 076375-001 Jan 14, 2003 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Impax Labs RIMANTADINE HYDROCHLORIDE rimantadine hydrochloride TABLET;ORAL 076132-001 Aug 30, 2002 RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm Inds Inc FLUMADINE rimantadine hydrochloride TABLET;ORAL 019649-001 Sep 17, 1993 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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