APPLICATION
NDA050545
TYPE
NDA
ORIGINAL APPROVAL
1981-12-29
LATEST ACTION
2008-04-17
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
PIPRACIL · ReferenceDiscontinued
PIPERACILLIN SODIUM EQ 3GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
PIPRACIL · ReferenceDiscontinued
PIPERACILLIN SODIUM EQ 40GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
PIPRACIL · ReferenceDiscontinued
PIPERACILLIN SODIUM EQ 4GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
PIPRACIL · ReferenceDiscontinued
PIPERACILLIN SODIUM EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2002-12-02Manufacturing (CMC) · Supplement 46 · priorityAP
2002-10-10Manufacturing (CMC) · Supplement 45 · priorityAP
2002-02-26Manufacturing (CMC) · Supplement 43 · priorityAP
2002-02-01Labeling · Supplement 42 · standardAP
2001-08-20Manufacturing (CMC) · Supplement 39 · priorityAP
2000-11-22Manufacturing (CMC) · Supplement 36 · priorityAP
1999-03-11Manufacturing (CMC) · Supplement 34 · priorityAP
1998-07-13Manufacturing (CMC) · Supplement 35 · priorityAP
1991-09-20Manufacturing (CMC) · Supplement 29 · priorityAP
1989-10-04Manufacturing (CMC) · Supplement 28 · priorityAP
1989-03-30Manufacturing (CMC) · Supplement 19 · priorityAP
1988-05-13Labeling · Supplement 27AP
1988-05-03Manufacturing (CMC) · Supplement 26 · priorityAP
1987-12-22Labeling · Supplement 25AP
1987-10-06Manufacturing (CMC) · Supplement 22 · priorityAP
1987-09-25Labeling · Supplement 24AP
1987-07-22Manufacturing (CMC) · Supplement 23 · priorityAP
1987-05-27Manufacturing (CMC) · Supplement 21 · priorityAP
1987-04-08Labeling · Supplement 20AP
1986-08-15Labeling · Supplement 18AP
1985-09-30Manufacturing (CMC) · Supplement 17 · priorityAP
1985-06-19Labeling · Supplement 14AP
1985-06-03Manufacturing (CMC) · Supplement 15 · priorityAP
1985-05-31Manufacturing (CMC) · Supplement 13 · priorityAP
1985-01-30Manufacturing (CMC) · Supplement 12 · priorityAP
1984-08-23Labeling · Supplement 11AP
1984-08-06Efficacy · Supplement 8AP
1984-08-06Efficacy · Supplement 1AP
1984-08-01Manufacturing (CMC) · Supplement 10 · priorityAP
1983-07-05Manufacturing (CMC) · Supplement 5 · priorityAP
1983-03-18Manufacturing (CMC) · Supplement 4 · priorityAP
1983-03-01Manufacturing (CMC) · Supplement 3 · priorityAP
1981-12-29Type 1 - New Molecular Entity · Original · priorityAP
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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