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FDA NDA · NDA050435

GEOCILLIN

Sponsor: PFIZER

APPLICATION
NDA050435
TYPE
NDA
ORIGINAL APPROVAL
1972-10-26
LATEST ACTION
2008-02-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

GEOCILLINDiscontinued
CARBENICILLIN INDANYL SODIUM EQ 382MG BASE · TABLET · ORAL

Approval history

2008-02-27Labeling · Supplement 9 · standardLetterAP
2004-12-23Labeling · Supplement 8 · standardLetterAP
1999-11-15Manufacturing (CMC) · Supplement 7AP
1992-07-17Manufacturing (CMC) · Supplement 6AP
1991-08-13Manufacturing (CMC) · Supplement 5AP
1972-10-26UNKNOWN · Original · unknownAP
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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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