Is there a generic for Rimantadine hydrochloride?

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Rimantadine hydrochloride, referencing the brand FLUMADINE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Rimantadine hydrochloride?

FLUMADINE (NDA 019649, SUN PHARM INDS INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Rimantadine hydrochloride are approved?

Rimantadine hydrochloride is approved in the following dosage forms: syrup, tablet.

FDA Orange Book · active-ingredient family

Rimantadine hydrochloride

Rimantadine hydrochloride is approved as 2 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:FLUMADINE · NDA 019649

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · syrup, tablet

Product	Applicant	Application	TE	Approved
FLUMADINERLD	SUN PHARM INDS INC	NDA 019649	—	Sep 17, 1993
FLUMADINE	FOREST LABS	NDA 019650	—	Sep 17, 1993

Generic (ANDA) products (3)

Product	Applicant	Application	TE	Approved
RIMANTADINE HYDROCHLORIDE	CHARTWELL RX	ANDA 076375	—	Jan 14, 2003
RIMANTADINE HYDROCHLORIDE	IMPAX LABS	ANDA 076132	—	Aug 30, 2002
RIMANTADINE HYDROCHLORIDE	IMPAX LABS INC	ANDA 075916	—	Nov 02, 2001

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Rimantadine hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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