Is there a generic for Tinidazole?

Yes. The FDA Orange Book lists 4 approved generic (ANDA) applications for Tinidazole, referencing the brand TINDAMAX. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Tinidazole?

TINDAMAX (NDA 021618, MISSION PHARMA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Tinidazole are approved?

Tinidazole is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Tinidazole

Tinidazole is approved as 1 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:TINDAMAX · NDA 021618

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
TINDAMAXRLD×2	MISSION PHARMA	NDA 021618	AB	May 17, 2004

Generic (ANDA) products (4)

Product	Applicant	Application	TE	Approved
TINIDAZOLE×2	EDENBRIDGE PHARMS	ANDA 203808	AB	Aug 04, 2015
TINIDAZOLE×2	UNIQUE	ANDA 202489	AB	Oct 09, 2013
TINIDAZOLE×2	CHARTWELL RX	ANDA 202044	AB	Apr 30, 2012
TINIDAZOLE×2	HIKMA	ANDA 201172	—	Apr 30, 2012

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.

Tinidazole — frequently asked questions

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

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