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 5 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 2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N050554-001 PRECEF 500MG/VIAL INJECTABLE / INJECTION 1984-05-24 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N050554-002 PRECEF 1GM/VIAL INJECTABLE / INJECTION 1984-05-24 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N050554-003 PRECEF 2GM/VIAL INJECTABLE / INJECTION 1984-05-24 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N050554-004 PRECEF 10GM/VIAL INJECTABLE / INJECTION 1984-05-24 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N050554-005 PRECEF 20GM/VIAL INJECTABLE / INJECTION 1984-05-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N050554-001 PRECEF 500MG/VIAL INJECTABLE / INJECTION 1984-05-24 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N050554-002 PRECEF 1GM/VIAL INJECTABLE / INJECTION 1984-05-24 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N050554-003 PRECEF 2GM/VIAL INJECTABLE / INJECTION 1984-05-24 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N050554-004 PRECEF 10GM/VIAL INJECTABLE / INJECTION 1984-05-24 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N050554-005 PRECEF 20GM/VIAL INJECTABLE / INJECTION 1984-05-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N050554-001 PRECEF 500MG/VIAL INJECTABLE / INJECTION 1984-05-24 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N050554-002 PRECEF 1GM/VIAL INJECTABLE / INJECTION 1984-05-24 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N050554-003 PRECEF 2GM/VIAL INJECTABLE / INJECTION 1984-05-24 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N050554-004 PRECEF 10GM/VIAL INJECTABLE / INJECTION 1984-05-24 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N050554-005 PRECEF 20GM/VIAL INJECTABLE / INJECTION 1984-05-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N050554-001 PRECEF 500MG/VIAL INJECTABLE / INJECTION 1984-05-24 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N050554-002 PRECEF 1GM/VIAL INJECTABLE / INJECTION 1984-05-24 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N050554-003 PRECEF 2GM/VIAL INJECTABLE / INJECTION 1984-05-24 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N050554-004 PRECEF 10GM/VIAL INJECTABLE / INJECTION 1984-05-24 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N050554-005 PRECEF 20GM/VIAL INJECTABLE / INJECTION 1984-05-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N050554-001 PRECEF 500MG/VIAL INJECTABLE / INJECTION 1984-05-24 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N050554-002 PRECEF 1GM/VIAL INJECTABLE / INJECTION 1984-05-24 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N050554-003 PRECEF 2GM/VIAL INJECTABLE / INJECTION 1984-05-24 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N050554-004 PRECEF 10GM/VIAL INJECTABLE / INJECTION 1984-05-24 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N050554-005 PRECEF 20GM/VIAL INJECTABLE / INJECTION 1984-05-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N050554-001 PRECEF 500MG/VIAL INJECTABLE / INJECTION 1984-05-24 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N050554-002 PRECEF 1GM/VIAL INJECTABLE / INJECTION 1984-05-24 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N050554-003 PRECEF 2GM/VIAL INJECTABLE / INJECTION 1984-05-24 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N050554-004 PRECEF 10GM/VIAL INJECTABLE / INJECTION 1984-05-24 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N050554-005 PRECEF 20GM/VIAL INJECTABLE / INJECTION 1984-05-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N050554-001 PRECEF 500MG/VIAL INJECTABLE / INJECTION 1984-05-24 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N050554-002 PRECEF 1GM/VIAL INJECTABLE / INJECTION 1984-05-24 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N050554-003 PRECEF 2GM/VIAL INJECTABLE / INJECTION 1984-05-24 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N050554-004 PRECEF 10GM/VIAL INJECTABLE / INJECTION 1984-05-24 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N050554-005 PRECEF 20GM/VIAL INJECTABLE / INJECTION 1984-05-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N050554-001 PRECEF 500MG/VIAL INJECTABLE / INJECTION 1984-05-24 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N050554-002 PRECEF 1GM/VIAL INJECTABLE / INJECTION 1984-05-24 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N050554-003 PRECEF 2GM/VIAL INJECTABLE / INJECTION 1984-05-24 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N050554-004 PRECEF 10GM/VIAL INJECTABLE / INJECTION 1984-05-24 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N050554-005 PRECEF 20GM/VIAL INJECTABLE / INJECTION 1984-05-24 f41ea6bd6efb…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.