Capastat Sulfate

NDA 50095, held by Epic Pharma LLC. Capreomycin Sulfate.

As of Nov 14, 2026, NDA 50095 (Capastat Sulfate), held by Epic Pharma LLC, was first approved by FDA on Jun 2, 1971, with 46 approved supplements and 0 published complete response letters.

First approved: Jun 2, 1971
Supplements approved: 46
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 47 submissions below

Date	Submission	Status	Documents
Jun 2, 1971	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Capastat SulfateEQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Capreomycin Sulfate	DiscontinuedReference drug

All 47 submissions, including labeling and manufacturing supplements


Jan 17, 2023	Supplement 78Labeling · Standard review	Approved	Label Letter
Oct 1, 2019	Supplement 74Labeling · Standard review	Approved	Letter
Jan 16, 2019	Supplement 72Labeling · Standard review	Approved	Letter Label
Jul 24, 2008	Supplement 62Labeling · Standard review	Approved	Label Letter
Jun 11, 2003	Supplement 44Labeling · Standard review	Approved	Letter Label
Oct 5, 2001	Supplement 43Manufacturing	Approved	None posted
Oct 3, 1996	Supplement 41Labeling · Standard review	Approved	None posted
Dec 21, 1995	Supplement 42Manufacturing	Approved	None posted
Sep 12, 1988	Supplement 9Labeling	Approved	None posted
Aug 12, 1987	Supplement 38Labeling	Approved	None posted
Jul 8, 1987	Supplement 37Labeling	Approved	None posted
Jul 8, 1987	Supplement 7Labeling	Approved	None posted
May 26, 1987	Supplement 36Labeling	Approved	None posted
May 26, 1987	Supplement 8Labeling	Approved	None posted
May 26, 1987	Supplement 6Labeling	Approved	None posted
Mar 6, 1987	Supplement 35Manufacturing	Approved	None posted
Dec 9, 1986	Supplement 5Labeling	Approved	None posted
Jan 18, 1985	Supplement 34Manufacturing	Approved	None posted
Jan 18, 1985	Supplement 4Labeling	Approved	None posted
Sep 26, 1983	Supplement 33Manufacturing	Approved	None posted
Sep 26, 1983	Supplement 3Labeling	Approved	None posted
Aug 23, 1983	Supplement 32Labeling	Approved	None posted
Aug 23, 1983	Supplement 2Labeling	Approved	None posted
Aug 5, 1983	Supplement 31Labeling	Approved	None posted
Aug 5, 1983	Supplement 1Labeling	Approved	None posted
Aug 31, 1982	Supplement 30Manufacturing	Approved	None posted
Apr 12, 1982	Supplement 29Manufacturing	Approved	None posted
May 29, 1981	Supplement 28Manufacturing	Approved	None posted
Mar 11, 1981	Supplement 27Labeling	Approved	None posted
Mar 4, 1981	Supplement 26Manufacturing	Approved	None posted
Feb 11, 1981	Supplement 25Manufacturing	Approved	None posted
Jun 3, 1980	Supplement 24Labeling	Approved	None posted
Jan 25, 1980	Supplement 23Manufacturing	Approved	None posted
Nov 3, 1978	Supplement 22Manufacturing	Approved	None posted
Sep 21, 1977	Supplement 21Manufacturing	Approved	None posted
Sep 12, 1977	Supplement 20Labeling	Approved	None posted
Dec 3, 1976	Supplement 19Labeling	Approved	None posted
Sep 14, 1976	Supplement 18Manufacturing	Approved	None posted
Oct 28, 1975	Supplement 17Labeling	Approved	None posted
Sep 23, 1975	Supplement 16Manufacturing	Approved	None posted
Sep 20, 1974	Supplement 15Manufacturing	Approved	None posted
Aug 28, 1973	Supplement 14Manufacturing	Approved	None posted
Jul 18, 1973	Supplement 13Labeling	Approved	None posted
Aug 29, 1972	Supplement 12Manufacturing	Approved	None posted
Feb 25, 1972	Supplement 11Labeling	Approved	None posted
Dec 20, 1971	Supplement 10Manufacturing	Approved	None posted
Jun 2, 1971	Original application	Approved	None posted

Identifiers

Application: NDA 50095
Drugs@FDA: Overview at FDA
Company: Epic Pharma

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters