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FDA ANDA · ANDA062750

PIPRACIL

Sponsor: WYETH PHARMS INC

APPLICATION
ANDA062750
TYPE
ANDA
ORIGINAL APPROVAL
1987-10-13
LATEST ACTION
2002-10-31
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

PIPRACILDiscontinued
PIPERACILLIN SODIUM EQ 3GM BASE/VIAL · INJECTABLE · INJECTION
PIPRACILDiscontinued
PIPERACILLIN SODIUM EQ 4GM BASE/VIAL · INJECTABLE · INJECTION
PIPRACILDiscontinued
PIPERACILLIN SODIUM EQ 2GM BASE/VIAL · INJECTABLE · INJECTION

Approval history

2002-10-31Manufacturing (CMC) · Supplement 17AP
2002-10-31Labeling · Supplement 16AP
2002-10-25Manufacturing (CMC) · Supplement 19AP
2002-10-15Manufacturing (CMC) · Supplement 20AP
2002-03-27Manufacturing (CMC) · Supplement 18AP
2001-10-12Manufacturing (CMC) · Supplement 13AP
2000-12-27Manufacturing (CMC) · Supplement 10AP
1999-02-22Manufacturing (CMC) · Supplement 8AP
1998-07-29Manufacturing (CMC) · Supplement 9AP
1995-12-15Manufacturing (CMC) · Supplement 7AP
1992-10-30Manufacturing (CMC) · Supplement 6AP
1992-01-21Manufacturing (CMC) · Supplement 5AP
1989-10-04Manufacturing (CMC) · Supplement 3AP
1987-10-13OriginalAP
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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