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 2 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 2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050554-001 PRECEF 500MG/VIAL INJECTABLE / INJECTION 1984-05-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050554-002 PRECEF 1GM/VIAL INJECTABLE / INJECTION 1984-05-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050554-003 PRECEF 2GM/VIAL INJECTABLE / INJECTION 1984-05-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050554-004 PRECEF 10GM/VIAL INJECTABLE / INJECTION 1984-05-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050554-005 PRECEF 20GM/VIAL INJECTABLE / INJECTION 1984-05-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050554-001 PRECEF 500MG/VIAL INJECTABLE / INJECTION 1984-05-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050554-002 PRECEF 1GM/VIAL INJECTABLE / INJECTION 1984-05-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050554-003 PRECEF 2GM/VIAL INJECTABLE / INJECTION 1984-05-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050554-004 PRECEF 10GM/VIAL INJECTABLE / INJECTION 1984-05-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050554-005 PRECEF 20GM/VIAL INJECTABLE / INJECTION 1984-05-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050554-001 PRECEF 500MG/VIAL INJECTABLE / INJECTION 1984-05-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050554-002 PRECEF 1GM/VIAL INJECTABLE / INJECTION 1984-05-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050554-003 PRECEF 2GM/VIAL INJECTABLE / INJECTION 1984-05-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050554-004 PRECEF 10GM/VIAL INJECTABLE / INJECTION 1984-05-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050554-005 PRECEF 20GM/VIAL INJECTABLE / INJECTION 1984-05-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050554-001 PRECEF 500MG/VIAL INJECTABLE / INJECTION 1984-05-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050554-002 PRECEF 1GM/VIAL INJECTABLE / INJECTION 1984-05-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050554-003 PRECEF 2GM/VIAL INJECTABLE / INJECTION 1984-05-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050554-004 PRECEF 10GM/VIAL INJECTABLE / INJECTION 1984-05-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050554-005 PRECEF 20GM/VIAL INJECTABLE / INJECTION 1984-05-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050554-001 PRECEF 500MG/VIAL INJECTABLE / INJECTION 1984-05-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050554-002 PRECEF 1GM/VIAL INJECTABLE / INJECTION 1984-05-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050554-003 PRECEF 2GM/VIAL INJECTABLE / INJECTION 1984-05-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050554-004 PRECEF 10GM/VIAL INJECTABLE / INJECTION 1984-05-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050554-005 PRECEF 20GM/VIAL INJECTABLE / INJECTION 1984-05-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050554-001 PRECEF 500MG/VIAL INJECTABLE / INJECTION 1984-05-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050554-002 PRECEF 1GM/VIAL INJECTABLE / INJECTION 1984-05-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050554-003 PRECEF 2GM/VIAL INJECTABLE / INJECTION 1984-05-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050554-004 PRECEF 10GM/VIAL INJECTABLE / INJECTION 1984-05-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050554-005 PRECEF 20GM/VIAL INJECTABLE / INJECTION 1984-05-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050554-001 PRECEF 500MG/VIAL INJECTABLE / INJECTION 1984-05-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050554-002 PRECEF 1GM/VIAL INJECTABLE / INJECTION 1984-05-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050554-003 PRECEF 2GM/VIAL INJECTABLE / INJECTION 1984-05-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050554-004 PRECEF 10GM/VIAL INJECTABLE / INJECTION 1984-05-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050554-005 PRECEF 20GM/VIAL INJECTABLE / INJECTION 1984-05-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050554-001 PRECEF 500MG/VIAL INJECTABLE / INJECTION 1984-05-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N050554-002 PRECEF 1GM/VIAL INJECTABLE / INJECTION 1984-05-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N050554-003 PRECEF 2GM/VIAL INJECTABLE / INJECTION 1984-05-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N050554-004 PRECEF 10GM/VIAL INJECTABLE / INJECTION 1984-05-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N050554-005 PRECEF 20GM/VIAL INJECTABLE / INJECTION 1984-05-24 8072bd15b7f6…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.