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FDA ANDA · ANDA061601

AMPICILLIN TRIHYDRATE

Sponsor: BELCHER PHARMS

APPLICATION
ANDA061601
TYPE
ANDA
ORIGINAL APPROVAL
1974-03-06
LATEST ACTION
1997-07-22
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued

Products

AMPICILLIN TRIHYDRATEDiscontinued
AMPICILLIN/AMPICILLIN TRIHYDRATE EQ 125MG BASE/5ML · FOR SUSPENSION · ORAL
AMPICILLIN TRIHYDRATEDiscontinued
AMPICILLIN/AMPICILLIN TRIHYDRATE EQ 250MG BASE/5ML · FOR SUSPENSION · ORAL

Approval history

1997-07-22Labeling · Supplement 1AP
1974-03-06OriginalAP
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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