Home Applications 062579 Application 062579
Type ANDA
Sponsor APOTHECON 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 44 .
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 A062579-001 PRECEF CEFORANIDE 500MG/VIAL INJECTABLE / INJECTION 1984-11-26 A062579-002 PRECEF CEFORANIDE 1GM/VIAL INJECTABLE / INJECTION 1984-11-26 A062579-003 PRECEF CEFORANIDE 2GM/VIAL INJECTABLE / INJECTION 1984-11-26 A062579-004 PRECEF CEFORANIDE 10GM/VIAL INJECTABLE / INJECTION 1984-11-26 A062579-005 PRECEF CEFORANIDE 20GM/VIAL INJECTABLE / INJECTION 1984-11-26
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 · 220 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 2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062579-001 PRECEF 500MG/VIAL INJECTABLE / INJECTION 1984-11-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062579-002 PRECEF 1GM/VIAL INJECTABLE / INJECTION 1984-11-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062579-003 PRECEF 2GM/VIAL INJECTABLE / INJECTION 1984-11-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062579-004 PRECEF 10GM/VIAL INJECTABLE / INJECTION 1984-11-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062579-005 PRECEF 20GM/VIAL INJECTABLE / INJECTION 1984-11-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062579-001 PRECEF 500MG/VIAL INJECTABLE / INJECTION 1984-11-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062579-002 PRECEF 1GM/VIAL INJECTABLE / INJECTION 1984-11-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062579-003 PRECEF 2GM/VIAL INJECTABLE / INJECTION 1984-11-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062579-004 PRECEF 10GM/VIAL INJECTABLE / INJECTION 1984-11-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062579-005 PRECEF 20GM/VIAL INJECTABLE / INJECTION 1984-11-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062579-001 PRECEF 500MG/VIAL INJECTABLE / INJECTION 1984-11-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062579-002 PRECEF 1GM/VIAL INJECTABLE / INJECTION 1984-11-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062579-003 PRECEF 2GM/VIAL INJECTABLE / INJECTION 1984-11-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062579-004 PRECEF 10GM/VIAL INJECTABLE / INJECTION 1984-11-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062579-005 PRECEF 20GM/VIAL INJECTABLE / INJECTION 1984-11-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062579-001 PRECEF 500MG/VIAL INJECTABLE / INJECTION 1984-11-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062579-002 PRECEF 1GM/VIAL INJECTABLE / INJECTION 1984-11-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062579-003 PRECEF 2GM/VIAL INJECTABLE / INJECTION 1984-11-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062579-004 PRECEF 10GM/VIAL INJECTABLE / INJECTION 1984-11-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062579-005 PRECEF 20GM/VIAL INJECTABLE / INJECTION 1984-11-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A062579-001 PRECEF 500MG/VIAL INJECTABLE / INJECTION 1984-11-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A062579-002 PRECEF 1GM/VIAL INJECTABLE / INJECTION 1984-11-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A062579-003 PRECEF 2GM/VIAL INJECTABLE / INJECTION 1984-11-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A062579-004 PRECEF 10GM/VIAL INJECTABLE / INJECTION 1984-11-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A062579-005 PRECEF 20GM/VIAL INJECTABLE / INJECTION 1984-11-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062579-001 PRECEF 500MG/VIAL INJECTABLE / INJECTION 1984-11-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062579-002 PRECEF 1GM/VIAL INJECTABLE / INJECTION 1984-11-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062579-003 PRECEF 2GM/VIAL INJECTABLE / INJECTION 1984-11-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062579-004 PRECEF 10GM/VIAL INJECTABLE / INJECTION 1984-11-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062579-005 PRECEF 20GM/VIAL INJECTABLE / INJECTION 1984-11-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062579-001 PRECEF 500MG/VIAL INJECTABLE / INJECTION 1984-11-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062579-002 PRECEF 1GM/VIAL INJECTABLE / INJECTION 1984-11-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062579-003 PRECEF 2GM/VIAL INJECTABLE / INJECTION 1984-11-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062579-004 PRECEF 10GM/VIAL INJECTABLE / INJECTION 1984-11-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062579-005 PRECEF 20GM/VIAL INJECTABLE / INJECTION 1984-11-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062579-001 PRECEF 500MG/VIAL INJECTABLE / INJECTION 1984-11-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062579-002 PRECEF 1GM/VIAL INJECTABLE / INJECTION 1984-11-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062579-003 PRECEF 2GM/VIAL INJECTABLE / INJECTION 1984-11-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062579-004 PRECEF 10GM/VIAL INJECTABLE / INJECTION 1984-11-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062579-005 PRECEF 20GM/VIAL INJECTABLE / INJECTION 1984-11-26 1e350fbaab3a…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.