Home Applications 050545 Application 050545
Type NDA
Sponsor WYETH PHARMS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 002 PIPRACIL PIPERACILLIN SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 003 PIPRACIL PIPERACILLIN SODIUM INJECTABLE;INJECTION EQ 3GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 004 PIPRACIL PIPERACILLIN SODIUM INJECTABLE;INJECTION EQ 4GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 006 PIPRACIL PIPERACILLIN SODIUM INJECTABLE;INJECTION EQ 40GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050545-002 PIPRACIL PIPERACILLIN SODIUM EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD, Approved before 1982 N050545-003 PIPRACIL PIPERACILLIN SODIUM EQ 3GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD, Approved before 1982 N050545-004 PIPRACIL PIPERACILLIN SODIUM EQ 4GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD, Approved before 1982 N050545-006 PIPRACIL PIPERACILLIN SODIUM EQ 40GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1985-09-30
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 5 of 5 · 176 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 N050545-002 PIPRACIL EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD, Approved before 1982 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N050545-003 PIPRACIL EQ 3GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD, Approved before 1982 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N050545-004 PIPRACIL EQ 4GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD, Approved before 1982 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N050545-006 PIPRACIL EQ 40GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1985-09-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N050545-002 PIPRACIL EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD, Approved before 1982 e64feba35796…2022-09-29 23:25 UTC 2022-09 N050545-003 PIPRACIL EQ 3GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD, Approved before 1982 e64feba35796…2022-09-29 23:25 UTC 2022-09 N050545-004 PIPRACIL EQ 4GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD, Approved before 1982 e64feba35796…2022-09-29 23:25 UTC 2022-09 N050545-006 PIPRACIL EQ 40GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1985-09-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050545-002 PIPRACIL EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD, Approved before 1982 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050545-003 PIPRACIL EQ 3GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD, Approved before 1982 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050545-004 PIPRACIL EQ 4GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD, Approved before 1982 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050545-006 PIPRACIL EQ 40GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1985-09-30 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N050545-002 PIPRACIL EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD, Approved before 1982 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N050545-003 PIPRACIL EQ 3GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD, Approved before 1982 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N050545-004 PIPRACIL EQ 4GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD, Approved before 1982 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N050545-006 PIPRACIL EQ 40GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1985-09-30 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 38973 SUPPL 2008-06-05 7804 SUPPL 2008-04-22 30073 SUPPL 2005-07-29 7803 SUPPL 2005-07-29 30072 SUPPL 2004-04-07 30071 SUPPL 2003-06-08 30070 SUPPL 2003-06-08 7802 SUPPL 2003-06-08