Home Applications 063315 Application 063315
Type ANDA
Sponsor WEST-WARD PHARMS INT 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
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A063315-001 AMIKACIN SULFATE AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 1994-04-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A063315-001 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 · 41 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 A063315-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 1994-04-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A063315-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 1994-04-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A063315-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 1994-04-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A063315-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 1994-04-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A063315-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 1994-04-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A063315-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 1994-04-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A063315-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 1994-04-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A063315-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 1994-04-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A063315-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 1994-04-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A063315-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 1994-04-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A063315-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 1994-04-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A063315-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 1994-04-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A063315-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 1994-04-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A063315-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 1994-04-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A063315-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 1994-04-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A063315-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 1994-04-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A063315-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 1994-04-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A063315-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 1994-04-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A063315-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 1994-04-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A063315-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 1994-04-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A063315-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 1994-04-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A063315-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 1994-04-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A063315-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 1994-04-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A063315-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 1994-04-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A063315-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 1994-04-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A063315-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 1994-04-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A063315-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 1994-04-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A063315-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 1994-04-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A063315-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 1994-04-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A063315-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 1994-04-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A063315-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 1994-04-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A063315-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 1994-04-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A063315-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 1994-04-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A063315-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 1994-04-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A063315-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 1994-04-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A063315-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 1994-04-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A063315-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 1994-04-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A063315-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 1994-04-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A063315-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 1994-04-11 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A063315-001 AMIKACIN SULFATE EQ 250MG BASE/ML INJECTABLE / INJECTION AP 1994-04-11 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0641-6166 Amikacin Sulfate Amikacin Sulfate West-Ward Pharmaceuticals Corp. ANDA Current 0641-6166 Amikacin Sulfate Amikacin Sulfate Hikma Pharmaceuticals USA Inc. ANDA Current 0641-6167 Amikacin Sulfate Amikacin Sulfate West-Ward Pharmaceuticals Corp. ANDA Current 0641-6167 Amikacin Sulfate Amikacin Sulfate Hikma Pharmaceuticals USA Inc. ANDA Current