Is there a generic for Norfloxacin?

The FDA Orange Book does not currently list an approved generic (ANDA) for Norfloxacin. It is available as 2 brand (NDA) applications.

What is the reference-listed drug for Norfloxacin?

NOROXIN (NDA 019384, MERCK) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Norfloxacin are approved?

Norfloxacin is approved in the following dosage forms: solution/drops, tablet.

FDA Orange Book · active-ingredient family

Norfloxacin

Norfloxacin is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:NOROXIN · NDA 019384

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · solution/drops, tablet

Product	Applicant	Application	TE	Approved
NOROXINRLD	MERCK	NDA 019384	—	Oct 31, 1986
CHIBROXIN	MERCK	NDA 019757	—	Jun 17, 1991

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.

Norfloxacin — frequently asked questions

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

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