Home Applications 205179 Application 205179
Type ANDA
Sponsor AKORN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE INJECTABLE;INJECTION EQ 40MG 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 A205179-001 TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION 2014-09-16
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 A205179-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION 2014-09-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205179-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION 2014-09-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205179-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION 2014-09-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205179-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION 2014-09-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205179-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION 2014-09-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205179-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION 2014-09-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205179-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION 2014-09-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205179-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION 2014-09-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205179-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION 2014-09-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205179-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION 2014-09-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205179-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION 2014-09-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205179-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION 2014-09-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205179-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION 2014-09-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205179-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION 2014-09-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205179-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2014-09-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205179-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2014-09-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205179-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2014-09-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205179-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2014-09-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205179-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2014-09-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205179-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2014-09-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205179-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2014-09-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205179-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2014-09-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205179-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2014-09-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205179-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2014-09-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A205179-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2014-09-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205179-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2014-09-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A205179-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2014-09-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205179-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION 2014-09-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205179-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION 2014-09-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205179-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION 2014-09-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205179-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION 2014-09-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205179-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION 2014-09-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205179-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION 2014-09-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205179-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION 2014-09-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205179-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION 2014-09-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205179-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION 2014-09-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205179-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION 2014-09-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205179-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION 2014-09-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A205179-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION 2014-09-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A205179-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2014-09-16 cb3db0bc1861…
Observed Orange Book normalized TE history# 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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tobramycin TOBRAMYCIN SULFATE Fresenius Kabi USA, LLC 9a5cecd6-aa65-42d2-b15a-06b4fcebcc0f 2024-02-07 Boxed warning, Warnings, Adverse reactions Name fallback generic name: TOBRAMYCIN SULFATE Tobramycin TOBRAMYCIN SULFATE Fresenius Kabi USA, LLC d6dd9460-b030-479a-b3e3-03606e6fcad1 2024-02-05 Boxed warning, Warnings, Adverse reactions Name fallback generic name: TOBRAMYCIN SULFATE Tobramycin TOBRAMYCIN SULFATE Fresenius Kabi USA, LLC d62ff359-912b-4be1-9fc2-2dde8777eefb 2024-01-15 Boxed warning, Warnings, Adverse reactions Name fallback generic name: TOBRAMYCIN SULFATE
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 17478-114 Tobramycin Tobramycin Sulfate Akorn ANDA Current 17478-114 Tobramycin Tobramycin Sulfate Akorn, Inc. ANDA Current 17478-114 Tobramycin Tobramycin Sulfate Akorn, Inc. ANDA Current 17478-114 Tobramycin Tobramycin Sulfate Akorn, Inc. ANDA Current