Is there a generic for Alatrofloxacin mesylate?

The FDA Orange Book does not currently list an approved generic (ANDA) for Alatrofloxacin mesylate. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Alatrofloxacin mesylate?

TROVAN PRESERVATIVE FREE (NDA 020760, PFIZER) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Alatrofloxacin mesylate are approved?

Alatrofloxacin mesylate is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Alatrofloxacin mesylate

Alatrofloxacin mesylate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:TROVAN PRESERVATIVE FREE · NDA 020760

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
TROVAN PRESERVATIVE FREE×2	PFIZER	NDA 020760	—	Dec 18, 1997

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.

Alatrofloxacin mesylate — frequently asked questions

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

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