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: 1 brand, 2 generics; first approved Nov 27, 2017; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 2 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

CAPASTAT SULFATERLD

EPIC PHARMA LLCNDA 050095—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—

Abbreviated applications

Generic (ANDA) products (2)

CAPREOMYCIN SULFATE

HISUN PHARM HANGZHOUANDA 2047962018

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—

CAPREOMYCIN SULFATE

PHARMOBEDIENTANDA 2026342017

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—

Orange Book patent file

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.

FDA approval span

Approval history

First approval

Nov 27, 2017

8 yr 9 mo ago

Most recent approval

Oct 18, 2018

7 yr 10 mo ago

Approvals span 2017–2018 across 3 FDA applications.

Brand (NDA) 133%

Generic (ANDA) 267%

Capreomycin sulfate — frequently asked questions

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

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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