Home Applications 065124 Application 065124
Type ANDA
Sponsor LUPIN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CEFOTAXIME SODIUM CEFOTAXIME SODIUM INJECTABLE;INJECTION EQ 500MG BASE/VIAL No No 002 CEFOTAXIME SODIUM CEFOTAXIME SODIUM INJECTABLE;INJECTION EQ 1GM BASE/VIAL No No 003 CEFOTAXIME SODIUM CEFOTAXIME SODIUM INJECTABLE;INJECTION EQ 2GM BASE/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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065124-001 CEFOTAXIME SODIUM CEFOTAXIME SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2003-09-24 A065124-002 CEFOTAXIME SODIUM CEFOTAXIME SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2003-09-24 A065124-003 CEFOTAXIME SODIUM CEFOTAXIME SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2003-09-24
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 1 of 4 · 129 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 2026-09-14 22:38:34 2026-08 A065124-001 CEFOTAXIME SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2003-09-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A065124-002 CEFOTAXIME SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2003-09-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A065124-003 CEFOTAXIME SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2003-09-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065124-001 CEFOTAXIME SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2003-09-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065124-002 CEFOTAXIME SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2003-09-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065124-003 CEFOTAXIME SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2003-09-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065124-001 CEFOTAXIME SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2003-09-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065124-002 CEFOTAXIME SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2003-09-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065124-003 CEFOTAXIME SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2003-09-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065124-001 CEFOTAXIME SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2003-09-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065124-002 CEFOTAXIME SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2003-09-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065124-003 CEFOTAXIME SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2003-09-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065124-001 CEFOTAXIME SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2003-09-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065124-002 CEFOTAXIME SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2003-09-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065124-003 CEFOTAXIME SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2003-09-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065124-001 CEFOTAXIME SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2003-09-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065124-002 CEFOTAXIME SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2003-09-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065124-003 CEFOTAXIME SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2003-09-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065124-001 CEFOTAXIME SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2003-09-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065124-002 CEFOTAXIME SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2003-09-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065124-003 CEFOTAXIME SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2003-09-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065124-001 CEFOTAXIME SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2003-09-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065124-002 CEFOTAXIME SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2003-09-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065124-003 CEFOTAXIME SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2003-09-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065124-001 CEFOTAXIME SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2003-09-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065124-002 CEFOTAXIME SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2003-09-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065124-003 CEFOTAXIME SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2003-09-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065124-001 CEFOTAXIME SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2003-09-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065124-002 CEFOTAXIME SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2003-09-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065124-003 CEFOTAXIME SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2003-09-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065124-001 CEFOTAXIME SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2003-09-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065124-002 CEFOTAXIME SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2003-09-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065124-003 CEFOTAXIME SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2003-09-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065124-001 CEFOTAXIME SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2003-09-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065124-002 CEFOTAXIME SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2003-09-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065124-003 CEFOTAXIME SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2003-09-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065124-001 CEFOTAXIME SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2003-09-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065124-002 CEFOTAXIME SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2003-09-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065124-003 CEFOTAXIME SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION 2003-09-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065124-001 CEFOTAXIME SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2003-09-24 301d65b070ca…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 68180-811 CEFOTAXIME CEFOTAXIME Lupin Pharmaceuticals, Inc. ANDA Current 68180-822 CEFOTAXIME CEFOTAXIME Lupin Pharmaceuticals, Inc. ANDA Current 68180-833 CEFOTAXIME CEFOTAXIME Lupin Pharmaceuticals, Inc. ANDA Current