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 4 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 2020-12-22 03:56 UTC 2020-12 N050554-001 PRECEF 500MG/VIAL INJECTABLE / INJECTION 1984-05-24 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N050554-002 PRECEF 1GM/VIAL INJECTABLE / INJECTION 1984-05-24 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N050554-003 PRECEF 2GM/VIAL INJECTABLE / INJECTION 1984-05-24 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N050554-004 PRECEF 10GM/VIAL INJECTABLE / INJECTION 1984-05-24 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N050554-005 PRECEF 20GM/VIAL INJECTABLE / INJECTION 1984-05-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050554-001 PRECEF 500MG/VIAL INJECTABLE / INJECTION 1984-05-24 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N050554-002 PRECEF 1GM/VIAL INJECTABLE / INJECTION 1984-05-24 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N050554-003 PRECEF 2GM/VIAL INJECTABLE / INJECTION 1984-05-24 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N050554-004 PRECEF 10GM/VIAL INJECTABLE / INJECTION 1984-05-24 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N050554-005 PRECEF 20GM/VIAL INJECTABLE / INJECTION 1984-05-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050554-001 PRECEF 500MG/VIAL INJECTABLE / INJECTION 1984-05-24 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N050554-002 PRECEF 1GM/VIAL INJECTABLE / INJECTION 1984-05-24 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N050554-003 PRECEF 2GM/VIAL INJECTABLE / INJECTION 1984-05-24 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N050554-004 PRECEF 10GM/VIAL INJECTABLE / INJECTION 1984-05-24 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N050554-005 PRECEF 20GM/VIAL INJECTABLE / INJECTION 1984-05-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050554-001 PRECEF 500MG/VIAL INJECTABLE / INJECTION 1984-05-24 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N050554-002 PRECEF 1GM/VIAL INJECTABLE / INJECTION 1984-05-24 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N050554-003 PRECEF 2GM/VIAL INJECTABLE / INJECTION 1984-05-24 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N050554-004 PRECEF 10GM/VIAL INJECTABLE / INJECTION 1984-05-24 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N050554-005 PRECEF 20GM/VIAL INJECTABLE / INJECTION 1984-05-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050554-001 PRECEF 500MG/VIAL INJECTABLE / INJECTION 1984-05-24 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N050554-002 PRECEF 1GM/VIAL INJECTABLE / INJECTION 1984-05-24 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N050554-003 PRECEF 2GM/VIAL INJECTABLE / INJECTION 1984-05-24 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N050554-004 PRECEF 10GM/VIAL INJECTABLE / INJECTION 1984-05-24 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N050554-005 PRECEF 20GM/VIAL INJECTABLE / INJECTION 1984-05-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N050554-001 PRECEF 500MG/VIAL INJECTABLE / INJECTION 1984-05-24 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N050554-002 PRECEF 1GM/VIAL INJECTABLE / INJECTION 1984-05-24 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N050554-003 PRECEF 2GM/VIAL INJECTABLE / INJECTION 1984-05-24 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N050554-004 PRECEF 10GM/VIAL INJECTABLE / INJECTION 1984-05-24 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N050554-005 PRECEF 20GM/VIAL INJECTABLE / INJECTION 1984-05-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N050554-001 PRECEF 500MG/VIAL INJECTABLE / INJECTION 1984-05-24 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N050554-002 PRECEF 1GM/VIAL INJECTABLE / INJECTION 1984-05-24 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N050554-003 PRECEF 2GM/VIAL INJECTABLE / INJECTION 1984-05-24 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N050554-004 PRECEF 10GM/VIAL INJECTABLE / INJECTION 1984-05-24 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N050554-005 PRECEF 20GM/VIAL INJECTABLE / INJECTION 1984-05-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N050554-001 PRECEF 500MG/VIAL INJECTABLE / INJECTION 1984-05-24 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N050554-002 PRECEF 1GM/VIAL INJECTABLE / INJECTION 1984-05-24 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N050554-003 PRECEF 2GM/VIAL INJECTABLE / INJECTION 1984-05-24 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N050554-004 PRECEF 10GM/VIAL INJECTABLE / INJECTION 1984-05-24 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N050554-005 PRECEF 20GM/VIAL INJECTABLE / INJECTION 1984-05-24 ea1830bbd6c7…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.