← FDA DRUG APPROVALS

FDA NDA · NDA050095

CAPASTAT SULFATE

Sponsor: EPIC PHARMA LLC

APPLICATION
NDA050095
TYPE
NDA
ORIGINAL APPROVAL
1971-06-02
LATEST ACTION
2023-01-17
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

CAPASTAT SULFATE · ReferenceDiscontinued
CAPREOMYCIN SULFATE EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2023-01-17Labeling · Supplement 78 · standard — Label ↗AP
2019-10-01Labeling · Supplement 74 · standard — Letter ↗AP
2019-01-16Labeling · Supplement 72 · standard — Label ↗AP
2008-07-24Labeling · Supplement 62 · standard — Label ↗AP
2003-06-11Labeling · Supplement 44 · standard — Label ↗AP
2001-10-05Manufacturing (CMC) · Supplement 43AP
1996-10-03Labeling · Supplement 41 · standardAP
1995-12-21Manufacturing (CMC) · Supplement 42AP
1988-09-12Labeling · Supplement 9AP
1987-08-12Labeling · Supplement 38AP
1987-07-08Labeling · Supplement 7AP
1987-07-08Labeling · Supplement 37AP
1987-05-26Labeling · Supplement 8AP
1987-05-26Labeling · Supplement 6AP
1987-05-26Labeling · Supplement 36AP
1987-03-06Manufacturing (CMC) · Supplement 35AP
1986-12-09Labeling · Supplement 5AP
1985-01-18Labeling · Supplement 4AP
1985-01-18Manufacturing (CMC) · Supplement 34AP
1983-09-26Labeling · Supplement 3AP
1983-09-26Manufacturing (CMC) · Supplement 33AP
1983-08-23Labeling · Supplement 2AP
1983-08-23Labeling · Supplement 32AP
1983-08-05Labeling · Supplement 1AP
1983-08-05Labeling · Supplement 31AP
1982-08-31Manufacturing (CMC) · Supplement 30AP
1982-04-12Manufacturing (CMC) · Supplement 29AP
1981-05-29Manufacturing (CMC) · Supplement 28AP
1981-03-11Labeling · Supplement 27AP
1981-03-04Manufacturing (CMC) · Supplement 26AP
1981-02-11Manufacturing (CMC) · Supplement 25AP
1980-06-03Labeling · Supplement 24AP
1980-01-25Manufacturing (CMC) · Supplement 23AP
1978-11-03Manufacturing (CMC) · Supplement 22AP
1977-09-21Manufacturing (CMC) · Supplement 21AP
1977-09-12Labeling · Supplement 20AP
1976-12-03Labeling · Supplement 19AP
1976-09-14Manufacturing (CMC) · Supplement 18AP
1975-10-28Labeling · Supplement 17AP
1975-09-23Manufacturing (CMC) · Supplement 16AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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