← FDA DRUG APPROVALS

FDA NDA · NDA050608

UNASYN

ampicillin sodium and sulbactam sodium

Sponsor: PFIZER

APPLICATION
NDA050608
TYPE
NDA
ORIGINAL APPROVAL
1986-12-31
LATEST ACTION
2025-11-05
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued

Products

UNASYN · ReferencePrescription
AMPICILLIN SODIUM EQ 10GM BASE/VIAL, SULBACTAM SODIUM EQ 5GM BASE/VIAL · INJECTABLE · INJECTION
UNASYNDiscontinued
AMPICILLIN SODIUM EQ 500MG BASE/VIAL, SULBACTAM SODIUM EQ 250MG BASE/VIAL · INJECTABLE · INJECTION
UNASYN · ReferencePrescription
AMPICILLIN SODIUM EQ 2GM BASE/VIAL, SULBACTAM SODIUM EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
UNASYN · ReferencePrescription
AMPICILLIN SODIUM EQ 1GM BASE/VIAL, SULBACTAM SODIUM EQ 500MG BASE/VIAL · INJECTABLE · INJECTION

Approval history

2025-11-05Labeling · Supplement 58 · standard — Letter ↗AP
2025-01-31Labeling · Supplement 56 · standard — Letter ↗AP
2024-05-01Labeling · Supplement 53 · standard — Letter ↗AP
2020-10-09Labeling · Supplement 47 · standard — Letter ↗AP
2018-04-19Labeling · Supplement 46 · standard — Label ↗AP
2017-02-13Labeling · Supplement 44 · standard — Letter ↗AP
2015-02-09Manufacturing (CMC) · Supplement 43 · standardAP
2014-11-17Labeling · Supplement 41 · standard — Letter ↗AP
2014-11-17Labeling · Supplement 42 · standard — Label ↗AP
2012-12-14Manufacturing (CMC) · Supplement 38 · standardAP
2012-03-06Labeling · Supplement 40 · standard — Label ↗AP
2008-04-14Labeling · Supplement 29 · standard — Label ↗AP
2004-08-19Labeling · Supplement 26 · standard — Letter ↗AP
2002-03-13Manufacturing (CMC) · Supplement 25 · standardAP
2001-02-14Manufacturing (CMC) · Supplement 24 · standardAP
1998-05-29Manufacturing (CMC) · Supplement 23 · standardAP
1997-02-12Efficacy · Supplement 19 · standard — Review ↗AP
1996-12-06Manufacturing (CMC) · Supplement 21 · standardAP
1996-05-15Manufacturing (CMC) · Supplement 20 · standardAP
1993-12-10Manufacturing (CMC) · Supplement 18 · standardAP
1993-11-05Labeling · Supplement 17 · standardAP
1993-03-24Manufacturing (CMC) · Supplement 15 · standardAP
1992-10-08Labeling · Supplement 16AP
1992-05-08Manufacturing (CMC) · Supplement 14 · standardAP
1992-04-23Manufacturing (CMC) · Supplement 13 · standardAP
1992-03-27Labeling · Supplement 11AP
1992-01-02Manufacturing (CMC) · Supplement 12 · standardAP
1991-11-22Manufacturing (CMC) · Supplement 9 · standardAP
1989-08-03Manufacturing (CMC) · Supplement 7 · standardAP
1986-12-31Type 1 - New Molecular Entity and Type 4 - New Combination · Original · standard — Review ↗AP
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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