Is there a generic for Capreomycin sulfate?

Yes. The FDA Orange Book lists 2 approved generic (ANDA) applications for Capreomycin sulfate, referencing the brand CAPASTAT SULFATE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Capreomycin sulfate?

CAPASTAT SULFATE (NDA 050095, EPIC PHARMA LLC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Capreomycin sulfate are approved?

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

FDA Orange Book · active-ingredient family

Capreomycin sulfate

Capreomycin sulfate is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:CAPASTAT SULFATE · NDA 050095

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
CAPASTAT SULFATERLD	EPIC PHARMA LLC	NDA 050095	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (2)

Product	Applicant	Application	TE	Approved
CAPREOMYCIN SULFATE	HISUN PHARM HANGZHOU	ANDA 204796	—	Oct 18, 2018
CAPREOMYCIN SULFATE	PHARMOBEDIENT	ANDA 202634	—	Nov 27, 2017

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.

Capreomycin sulfate — frequently asked questions

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

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