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 3 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 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050554-001 PRECEF 500MG/VIAL INJECTABLE / INJECTION 1984-05-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050554-002 PRECEF 1GM/VIAL INJECTABLE / INJECTION 1984-05-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050554-003 PRECEF 2GM/VIAL INJECTABLE / INJECTION 1984-05-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050554-004 PRECEF 10GM/VIAL INJECTABLE / INJECTION 1984-05-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050554-005 PRECEF 20GM/VIAL INJECTABLE / INJECTION 1984-05-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050554-001 PRECEF 500MG/VIAL INJECTABLE / INJECTION 1984-05-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N050554-002 PRECEF 1GM/VIAL INJECTABLE / INJECTION 1984-05-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N050554-003 PRECEF 2GM/VIAL INJECTABLE / INJECTION 1984-05-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N050554-004 PRECEF 10GM/VIAL INJECTABLE / INJECTION 1984-05-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N050554-005 PRECEF 20GM/VIAL INJECTABLE / INJECTION 1984-05-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050554-001 PRECEF 500MG/VIAL INJECTABLE / INJECTION 1984-05-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N050554-002 PRECEF 1GM/VIAL INJECTABLE / INJECTION 1984-05-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N050554-003 PRECEF 2GM/VIAL INJECTABLE / INJECTION 1984-05-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N050554-004 PRECEF 10GM/VIAL INJECTABLE / INJECTION 1984-05-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N050554-005 PRECEF 20GM/VIAL INJECTABLE / INJECTION 1984-05-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050554-001 PRECEF 500MG/VIAL INJECTABLE / INJECTION 1984-05-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N050554-002 PRECEF 1GM/VIAL INJECTABLE / INJECTION 1984-05-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N050554-003 PRECEF 2GM/VIAL INJECTABLE / INJECTION 1984-05-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N050554-004 PRECEF 10GM/VIAL INJECTABLE / INJECTION 1984-05-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N050554-005 PRECEF 20GM/VIAL INJECTABLE / INJECTION 1984-05-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050554-001 PRECEF 500MG/VIAL INJECTABLE / INJECTION 1984-05-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N050554-002 PRECEF 1GM/VIAL INJECTABLE / INJECTION 1984-05-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N050554-003 PRECEF 2GM/VIAL INJECTABLE / INJECTION 1984-05-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N050554-004 PRECEF 10GM/VIAL INJECTABLE / INJECTION 1984-05-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N050554-005 PRECEF 20GM/VIAL INJECTABLE / INJECTION 1984-05-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050554-001 PRECEF 500MG/VIAL INJECTABLE / INJECTION 1984-05-24 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N050554-002 PRECEF 1GM/VIAL INJECTABLE / INJECTION 1984-05-24 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N050554-003 PRECEF 2GM/VIAL INJECTABLE / INJECTION 1984-05-24 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N050554-004 PRECEF 10GM/VIAL INJECTABLE / INJECTION 1984-05-24 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N050554-005 PRECEF 20GM/VIAL INJECTABLE / INJECTION 1984-05-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050554-001 PRECEF 500MG/VIAL INJECTABLE / INJECTION 1984-05-24 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050554-002 PRECEF 1GM/VIAL INJECTABLE / INJECTION 1984-05-24 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050554-003 PRECEF 2GM/VIAL INJECTABLE / INJECTION 1984-05-24 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050554-004 PRECEF 10GM/VIAL INJECTABLE / INJECTION 1984-05-24 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050554-005 PRECEF 20GM/VIAL INJECTABLE / INJECTION 1984-05-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050554-001 PRECEF 500MG/VIAL INJECTABLE / INJECTION 1984-05-24 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N050554-002 PRECEF 1GM/VIAL INJECTABLE / INJECTION 1984-05-24 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N050554-003 PRECEF 2GM/VIAL INJECTABLE / INJECTION 1984-05-24 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N050554-004 PRECEF 10GM/VIAL INJECTABLE / INJECTION 1984-05-24 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N050554-005 PRECEF 20GM/VIAL INJECTABLE / INJECTION 1984-05-24 5aa47cf7b7d7…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.