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FDA NDA · NDA050643

ZINACEF IN PLASTIC CONTAINER

Sponsor: PAI HOLDINGS PHARM

APPLICATION
NDA050643
TYPE
NDA
ORIGINAL APPROVAL
1989-04-28
LATEST ACTION
2021-05-16
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

ZINACEF IN PLASTIC CONTAINER · ReferenceDiscontinued
CEFUROXIME SODIUM EQ 30MG BASE/ML · INJECTABLE · INJECTION
ZINACEF IN PLASTIC CONTAINERDiscontinued
CEFUROXIME SODIUM EQ 15MG BASE/ML · INJECTABLE · INJECTION

Approval history

2021-05-16Labeling · Supplement 27 · standard — Letter ↗AP
2014-09-25Labeling · Supplement 22 · standard — Label ↗AP
2013-04-29Manufacturing (CMC) · Supplement 25 · standardAP
2007-07-30Labeling · Supplement 21 · standard — Label ↗AP
2004-05-19Labeling · Supplement 15 · standard — Label ↗AP
2001-11-09Manufacturing (CMC) · Supplement 13 · standardAP
2001-10-12Labeling · Supplement 11 · standard — Label ↗AP
2001-07-12Labeling · Supplement 10 · standardAP
2001-04-13Manufacturing (CMC) · Supplement 12 · standardAP
1996-12-23Labeling · Supplement 9 · standardAP
1996-12-23Labeling · Supplement 7 · standardAP
1996-09-11Labeling · Supplement 8 · standardAP
1995-10-23Labeling · Supplement 2AP
1995-09-29Labeling · Supplement 6 · standardAP
1995-02-06Labeling · Supplement 4 · standardAP
1994-10-27Labeling · Supplement 5 · standardAP
1993-01-15Manufacturing (CMC) · Supplement 1 · standardAP
1992-03-30Manufacturing (CMC) · Supplement 3 · standardAP
1989-04-28Type 3 - New Dosage Form · Original · standardAP
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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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