Home Applications 050565 Application 050565
Type NDA
Sponsor ROCHE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 COACTIN AMDINOCILLIN INJECTABLE;INJECTION 250MG/VIAL No No 002 COACTIN AMDINOCILLIN INJECTABLE;INJECTION 500MG/VIAL No No 003 COACTIN AMDINOCILLIN INJECTABLE;INJECTION 1GM/VIAL No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050565-001 COACTIN AMDINOCILLIN 250MG/VIAL INJECTABLE / INJECTION 1984-12-21 N050565-002 COACTIN AMDINOCILLIN 500MG/VIAL INJECTABLE / INJECTION 1984-12-21 N050565-003 COACTIN AMDINOCILLIN 1GM/VIAL INJECTABLE / INJECTION 1984-12-21
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 4 · 132 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 2022-10-28 04:53 UTC 2022-10 N050565-001 COACTIN 250MG/VIAL INJECTABLE / INJECTION 1984-12-21 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N050565-002 COACTIN 500MG/VIAL INJECTABLE / INJECTION 1984-12-21 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N050565-003 COACTIN 1GM/VIAL INJECTABLE / INJECTION 1984-12-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N050565-001 COACTIN 250MG/VIAL INJECTABLE / INJECTION 1984-12-21 e64feba35796…2022-09-29 23:25 UTC 2022-09 N050565-002 COACTIN 500MG/VIAL INJECTABLE / INJECTION 1984-12-21 e64feba35796…2022-09-29 23:25 UTC 2022-09 N050565-003 COACTIN 1GM/VIAL INJECTABLE / INJECTION 1984-12-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050565-001 COACTIN 250MG/VIAL INJECTABLE / INJECTION 1984-12-21 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050565-002 COACTIN 500MG/VIAL INJECTABLE / INJECTION 1984-12-21 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050565-003 COACTIN 1GM/VIAL INJECTABLE / INJECTION 1984-12-21 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N050565-001 COACTIN 250MG/VIAL INJECTABLE / INJECTION 1984-12-21 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N050565-002 COACTIN 500MG/VIAL INJECTABLE / INJECTION 1984-12-21 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N050565-003 COACTIN 1GM/VIAL INJECTABLE / INJECTION 1984-12-21 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.