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FDA ANDA · ANDA065316

AMPICILLIN AND SULBACTAM

Sponsor: EUROFARMA

APPLICATION
ANDA065316
TYPE
ANDA
ORIGINAL APPROVAL
2007-06-29
LATEST ACTION
2016-04-08
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

AMPICILLIN AND SULBACTAMDiscontinued
AMPICILLIN SODIUM EQ 2GM BASE/VIAL, SULBACTAM SODIUM EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
AMPICILLIN AND SULBACTAMDiscontinued
AMPICILLIN SODIUM EQ 1GM BASE/VIAL, SULBACTAM SODIUM EQ 500MG BASE/VIAL · INJECTABLE · INJECTION

Approval history

2016-04-08Labeling · Supplement 9 · standardAP
2016-04-08Labeling · Supplement 8 · standardAP
2013-07-15Labeling · Supplement 5AP
2013-07-15Labeling · Supplement 6 · standardAP
2007-06-29OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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