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FDA NDA · NDA050558

ZINACEF

Sponsor: PAI HOLDINGS PHARM

APPLICATION
NDA050558
TYPE
NDA
ORIGINAL APPROVAL
1983-10-19
LATEST ACTION
2021-05-16
ROUTE
INJECTION, INTRAMUSCULAR, INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

ZINACEF · ReferenceDiscontinued
CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
ZINACEF · ReferenceDiscontinued
CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
ZINACEF · ReferenceDiscontinued
CEFUROXIME SODIUM EQ 750MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INTRAMUSCULAR, INTRAVENOUS

Approval history

2021-05-16Labeling · Supplement 76 · standard — Letter ↗AP
2020-02-11Labeling · Supplement 75 · standard — Letter ↗AP
2015-03-16Manufacturing (CMC) · Supplement 73 · standardAP
2014-09-25Labeling · Supplement 69 · standard — Letter ↗AP
2013-08-14Manufacturing (CMC) · Supplement 72 · standardAP
2007-07-30Labeling · Supplement 67 · standard — Label ↗AP
2004-05-19Labeling · Supplement 57 · standard — Label ↗AP
2002-10-23Manufacturing (CMC) · Supplement 54 · standardAP
2001-11-09Manufacturing (CMC) · Supplement 53 · standardAP
2001-10-12Labeling · Supplement 50 · standard — Label ↗AP
2001-07-12Labeling · Supplement 49 · standardAP
2001-05-05Manufacturing (CMC) · Supplement 52 · standardAP
2001-04-13Manufacturing (CMC) · Supplement 51 · standardAP
1997-04-03Manufacturing (CMC) · Supplement 48 · standardAP
1996-12-23Labeling · Supplement 47 · standardAP
1996-12-23Labeling · Supplement 44 · standardAP
1996-09-11Labeling · Supplement 45 · standardAP
1995-10-31Manufacturing (CMC) · Supplement 46 · standardAP
1995-10-23Labeling · Supplement 31AP
1995-09-29Labeling · Supplement 43 · standardAP
1995-02-06Labeling · Supplement 37 · standardAP
1994-10-27Labeling · Supplement 41 · standardAP
1993-06-28Manufacturing (CMC) · Supplement 42 · standardAP
1993-02-18Manufacturing (CMC) · Supplement 36 · standardAP
1992-12-31Labeling · Supplement 40AP
1992-11-04Manufacturing (CMC) · Supplement 30 · standardAP
1992-09-23Manufacturing (CMC) · Supplement 35 · standardAP
1992-02-13Manufacturing (CMC) · Supplement 29 · standardAP
1992-02-13Manufacturing (CMC) · Supplement 28 · standardAP
1992-02-13Manufacturing (CMC) · Supplement 32 · standardAP
1991-08-14Manufacturing (CMC) · Supplement 33 · standardAP
1990-03-22Manufacturing (CMC) · Supplement 27 · standardAP
1989-06-30Labeling · Supplement 26AP
1989-03-24Manufacturing (CMC) · Supplement 25 · standardAP
1988-05-12Labeling · Supplement 20AP
1987-09-25Manufacturing (CMC) · Supplement 24 · standardAP
1987-08-28Labeling · Supplement 23AP
1987-08-13Manufacturing (CMC) · Supplement 22 · standardAP
1986-10-23Labeling · Supplement 19AP
1986-05-30Manufacturing (CMC) · Supplement 18 · standardAP
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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