Home Applications 201422 Application 201422
Type ANDA
Sponsor AKORN INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TOBRAMYCIN TOBRAMYCIN SOLUTION;INHALATION 300MG/5ML 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 A201422-001 TOBRAMYCIN TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A201422-001 AN
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 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tobramycin TOBRAMYCIN Ritedose Pharmaceuticals, LLC e8205898-0162-4e6c-bcf1-87cb074ab9ae 2025-12-10 Warnings, Adverse reactions Exact identifier application applno (ANDA): 201422 application number: ANDA201422
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 17478-340 Tobramycin Tobramycin Akorn, Inc. ANDA Current 17478-340 Tobramycin Tobramycin Akorn ANDA Current 17478-340 Tobramycin Tobramycin Akorn, Inc. ANDA Current 17478-340 Tobramycin Tobramycin Akorn ANDA Current 17478-340 Tobramycin Tobramycin Akorn, Inc. ANDA Current 17478-340 Tobramycin Tobramycin Akorn, Inc. ANDA Current 65302-063 Tobramycin Inhalation Solution Tobramycin The Ritedose Corporation ANDA Current