Is there a generic for Vinblastine sulfate?

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

What is the reference-listed drug for Vinblastine sulfate?

VELBAN (NDA 012665, LILLY) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Vinblastine sulfate are approved?

Vinblastine sulfate is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Vinblastine sulfate

Vinblastine sulfate 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:VELBAN · NDA 012665

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
VELBANRLD	LILLY	NDA 012665	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (4)

Product	Applicant	Application	TE	Approved
VINBLASTINE SULFATE	HOSPIRA	ANDA 089565	—	Aug 18, 1987
VINBLASTINE SULFATE	FRESENIUS KABI USA	ANDA 089515	—	Apr 29, 1987
VINBLASTINE SULFATE	HIKMA	ANDA 089395	—	Apr 09, 1987
VINBLASTINE SULFATE	ABRAXIS PHARM	ANDA 089011	—	Nov 18, 1985

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.

Vinblastine sulfate — frequently asked questions

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

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