Home Applications 062591 Application 062591
Type ANDA
Sponsor ACS DOBFAR Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 KEFUROX CEFUROXIME SODIUM INJECTABLE;INTRAMUSCULAR, INTRAVENOUS EQ 750MG BASE/VIAL No No 002 KEFUROX CEFUROXIME SODIUM INJECTABLE;INJECTION EQ 1.5GM BASE/VIAL No No 003 KEFUROX CEFUROXIME SODIUM INJECTABLE;INJECTION EQ 7.5GM BASE/VIAL No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A062591-001 KEFUROX CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS 1986-01-10 A062591-002 KEFUROX CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION 1986-01-10 A062591-003 KEFUROX CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION 1987-12-17
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 1 of 4 · 123 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 2026-02-19 14:30 UTC 2026-02 A062591-001 KEFUROX EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS 1986-01-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A062591-002 KEFUROX EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION 1986-01-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A062591-003 KEFUROX EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION 1987-12-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062591-001 KEFUROX EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS 1986-01-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062591-002 KEFUROX EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION 1986-01-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062591-003 KEFUROX EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION 1987-12-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A062591-001 KEFUROX EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS 1986-01-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A062591-002 KEFUROX EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION 1986-01-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A062591-003 KEFUROX EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION 1987-12-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062591-001 KEFUROX EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS 1986-01-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062591-002 KEFUROX EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION 1986-01-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062591-003 KEFUROX EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION 1987-12-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062591-001 KEFUROX EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS 1986-01-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062591-002 KEFUROX EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION 1986-01-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062591-003 KEFUROX EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION 1987-12-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062591-001 KEFUROX EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS 1986-01-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062591-002 KEFUROX EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION 1986-01-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062591-003 KEFUROX EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION 1987-12-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062591-001 KEFUROX EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS 1986-01-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062591-002 KEFUROX EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION 1986-01-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062591-003 KEFUROX EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION 1987-12-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062591-001 KEFUROX EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS 1986-01-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062591-002 KEFUROX EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION 1986-01-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062591-003 KEFUROX EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION 1987-12-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062591-001 KEFUROX EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS 1986-01-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062591-002 KEFUROX EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION 1986-01-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062591-003 KEFUROX EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION 1987-12-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A062591-001 KEFUROX EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS 1986-01-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A062591-002 KEFUROX EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION 1986-01-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A062591-003 KEFUROX EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION 1987-12-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062591-001 KEFUROX EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS 1986-01-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062591-002 KEFUROX EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION 1986-01-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062591-003 KEFUROX EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION 1987-12-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062591-001 KEFUROX EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS 1986-01-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062591-002 KEFUROX EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION 1986-01-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062591-003 KEFUROX EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION 1987-12-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062591-001 KEFUROX EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS 1986-01-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062591-002 KEFUROX EQ 1.5GM BASE/VIAL INJECTABLE / INJECTION 1986-01-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062591-003 KEFUROX EQ 7.5GM BASE/VIAL INJECTABLE / INJECTION 1987-12-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A062591-001 KEFUROX EQ 750MG BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS 1986-01-10 8072bd15b7f6…
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.