Home Applications 050554 Application 050554
Type NDA
Sponsor BRISTOL Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PRECEF CEFORANIDE INJECTABLE;INJECTION 500MG/VIAL No No 002 PRECEF CEFORANIDE INJECTABLE;INJECTION 1GM/VIAL No No 003 PRECEF CEFORANIDE INJECTABLE;INJECTION 2GM/VIAL No No 004 PRECEF CEFORANIDE INJECTABLE;INJECTION 10GM/VIAL No No 005 PRECEF CEFORANIDE INJECTABLE;INJECTION 20GM/VIAL No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050554-001 PRECEF CEFORANIDE 500MG/VIAL INJECTABLE / INJECTION 1984-05-24 N050554-002 PRECEF CEFORANIDE 1GM/VIAL INJECTABLE / INJECTION 1984-05-24 N050554-003 PRECEF CEFORANIDE 2GM/VIAL INJECTABLE / INJECTION 1984-05-24 N050554-004 PRECEF CEFORANIDE 10GM/VIAL INJECTABLE / INJECTION 1984-05-24 N050554-005 PRECEF CEFORANIDE 20GM/VIAL INJECTABLE / INJECTION 1984-05-24
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 6 of 6 · 215 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 2022-09-29 23:25 UTC 2022-09 N050554-001 PRECEF 500MG/VIAL INJECTABLE / INJECTION 1984-05-24 e64feba35796…2022-09-29 23:25 UTC 2022-09 N050554-002 PRECEF 1GM/VIAL INJECTABLE / INJECTION 1984-05-24 e64feba35796…2022-09-29 23:25 UTC 2022-09 N050554-003 PRECEF 2GM/VIAL INJECTABLE / INJECTION 1984-05-24 e64feba35796…2022-09-29 23:25 UTC 2022-09 N050554-004 PRECEF 10GM/VIAL INJECTABLE / INJECTION 1984-05-24 e64feba35796…2022-09-29 23:25 UTC 2022-09 N050554-005 PRECEF 20GM/VIAL INJECTABLE / INJECTION 1984-05-24 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050554-001 PRECEF 500MG/VIAL INJECTABLE / INJECTION 1984-05-24 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050554-002 PRECEF 1GM/VIAL INJECTABLE / INJECTION 1984-05-24 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050554-003 PRECEF 2GM/VIAL INJECTABLE / INJECTION 1984-05-24 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050554-004 PRECEF 10GM/VIAL INJECTABLE / INJECTION 1984-05-24 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050554-005 PRECEF 20GM/VIAL INJECTABLE / INJECTION 1984-05-24 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N050554-001 PRECEF 500MG/VIAL INJECTABLE / INJECTION 1984-05-24 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N050554-002 PRECEF 1GM/VIAL INJECTABLE / INJECTION 1984-05-24 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N050554-003 PRECEF 2GM/VIAL INJECTABLE / INJECTION 1984-05-24 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N050554-004 PRECEF 10GM/VIAL INJECTABLE / INJECTION 1984-05-24 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N050554-005 PRECEF 20GM/VIAL INJECTABLE / INJECTION 1984-05-24 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.