Home Applications 203323 Application 203323
Type ANDA
Sponsor SAGENT PHARMS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AMIKACIN SULFATE AMIKACIN SULFATE INJECTABLE;INJECTION EQ 250MG BASE/ML No No 002 AMIKACIN SULFATE AMIKACIN SULFATE INJECTABLE;INJECTION 500MG(BASE)/ML(250MG/ML) Yes No 003 AMIKACIN SULFATE AMIKACIN SULFATE INJECTABLE;INJECTION 1G(BASE)/4ML(250MG/ML) Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203323-001 AMIKACIN SULFATE AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2016-05-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203323-001 AP
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 2 · 42 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 2026-08-18 06:07:40 2026-07 A203323-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2016-05-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203323-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2016-05-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203323-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2016-05-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203323-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2016-05-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203323-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2016-05-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203323-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2016-05-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203323-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2016-05-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203323-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2016-05-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203323-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2016-05-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203323-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2016-05-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203323-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2016-05-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203323-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2016-05-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203323-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2016-05-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203323-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2016-05-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203323-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2016-05-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203323-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2016-05-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203323-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2016-05-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203323-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2016-05-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203323-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2016-05-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203323-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2016-05-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203323-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2016-05-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203323-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2016-05-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203323-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2016-05-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203323-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2016-05-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203323-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2016-05-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203323-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2016-05-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203323-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2016-05-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203323-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2016-05-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203323-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2016-05-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203323-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2016-05-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203323-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2016-05-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203323-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2016-05-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203323-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2016-05-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203323-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2016-05-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203323-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2016-05-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203323-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2016-05-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203323-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2016-05-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203323-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2016-05-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203323-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2016-05-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203323-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 2016-05-12 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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.
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 25021-173 amikacin sulfate amikacin sulfate Sagent Pharmaceuticals ANDA Current 25021-173 amikacin sulfate amikacin sulfate Sagent Pharmaceuticals ANDA Current 25021-173 amikacin sulfate amikacin sulfate Sagent Pharmaceuticals ANDA Current