Application 209554

Type: ANDA
Sponsor: MYLAN

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 43.

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
A209554-001	TOBRAMYCIN	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION			2017-10-13

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A209554-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2017-10-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209554-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2017-10-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209554-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2017-10-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209554-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2017-10-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209554-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2017-10-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209554-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2017-10-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209554-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2017-10-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209554-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2017-10-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209554-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2017-10-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209554-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2017-10-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209554-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2017-10-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209554-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2017-10-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209554-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2017-10-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209554-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2017-10-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209554-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2017-10-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209554-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2017-10-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209554-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2017-10-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209554-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2017-10-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209554-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2017-10-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209554-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2017-10-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209554-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2017-10-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209554-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2017-10-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209554-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2017-10-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209554-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2017-10-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209554-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2017-10-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209554-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2017-10-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209554-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2017-10-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209554-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2017-10-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209554-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN	2017-10-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209554-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2017-10-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209554-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2017-10-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209554-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2017-10-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209554-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2017-10-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209554-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2017-10-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209554-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2017-10-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209554-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2017-10-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209554-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2017-10-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209554-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2017-10-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209554-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2017-10-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209554-001	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION		2017-10-13	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A209554-001	AN	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A209554-001	AN	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209554-001	AN	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209554-001	AN	1	`ea99ee380514…`

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 2 of 3 · 58 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tobramycin	TOBRAMYCIN	Somerset Therapeutics, LLC	7333280d-5d2a-4609-ab93-3ab7031b65db	2025-07-10	Warnings, Adverse reactions	Name fallback brand name: Tobramycin generic name: TOBRAMYCIN
Tobramycin	TOBRAMYCIN SOLUTION	Micro Labs Limited	9d8b7b6c-3072-48e9-87c8-51160b9df9bc	2025-07-02	Warnings, Adverse reactions	Name fallback brand name: Tobramycin
Tobramycin	TOBRAMYCIN	Lupin Pharmaceuticals, Inc.	fd871ae7-9083-4e57-aacb-f584c1390db9	2025-07-01	Warnings, Adverse reactions	Name fallback brand name: Tobramycin generic name: TOBRAMYCIN
Tobramycin	TOBRAMYCIN	Belcher Pharmaceuticals, LLC	17b5b083-79ab-46b5-bed6-866e5415c623	2025-02-11	Warnings, Adverse reactions	Name fallback brand name: Tobramycin generic name: TOBRAMYCIN
Tobramycin Inhalation Solution Pak	TOBRAMYCIN	Genericus, Inc.	dad13445-f591-4829-96f9-1598ba03dff8	2024-12-13	Warnings, Adverse reactions	Name fallback generic name: TOBRAMYCIN
Tobramycin	TOBRAMYCIN	Advanced Rx Pharmacy of Tennessee, LLC	fc734c2d-0d45-195c-e053-6394a90a2a92	2024-12-03	Warnings, Adverse reactions	Name fallback brand name: Tobramycin generic name: TOBRAMYCIN
Kitabis Pak	TOBRAMYCIN	Pari Respiratory Equipment, Inc.	da1e5afd-d707-4af1-8935-8195ba6d769f	2024-11-22	Warnings, Adverse reactions	Name fallback generic name: TOBRAMYCIN
Tobramycin	TOBRAMYCIN	NuCare Pharmaceuticals,Inc.	58b1fa9d-a302-6dc6-e053-2991aa0a3741	2024-08-14	Warnings, Adverse reactions	Name fallback brand name: Tobramycin generic name: TOBRAMYCIN
TOBRAMYCIN	TOBRAMYCIN	Eugia US LLC	c37c251f-92e9-40f0-8b0c-00d42875d776	2024-07-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TOBRAMYCIN generic name: TOBRAMYCIN
Tobramycin	TOBRAMYCIN	NorthStar RxLLC	634efd82-1a35-40cf-9893-50c27d661083	2024-06-24	Warnings, Adverse reactions	Name fallback brand name: Tobramycin generic name: TOBRAMYCIN
Tobramycin	TOBRAMYCIN	Asclemed USA, Inc.	c6f9c6b1-2c45-4f6b-a1fb-e55d74fc04c3	2024-03-20	Warnings, Adverse reactions	Name fallback brand name: Tobramycin generic name: TOBRAMYCIN
Tobramycin	TOBRAMYCIN SULFATE	Fresenius Kabi USA, LLC	9a5cecd6-aa65-42d2-b15a-06b4fcebcc0f	2024-02-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tobramycin
Tobramycin	TOBRAMYCIN SULFATE	Fresenius Kabi USA, LLC	d6dd9460-b030-479a-b3e3-03606e6fcad1	2024-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tobramycin
Tobramycin	TOBRAMYCIN SULFATE	Fresenius Kabi USA, LLC	d62ff359-912b-4be1-9fc2-2dde8777eefb	2024-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tobramycin
TOBRAMYCIN	TOBRAMYCIN	DirectRX	87349ae8-4709-7f5a-e053-2a91aa0ae3d1	2024-01-10	Warnings, Adverse reactions	Name fallback brand name: TOBRAMYCIN generic name: TOBRAMYCIN
Tobramycin	TOBRAMYCIN	Ascend Laboratories, LLC	845e3328-fffa-44eb-b78a-3607c05fdd55	2024-01-09	Warnings, Adverse reactions	Name fallback brand name: Tobramycin generic name: TOBRAMYCIN
Tobramycin	TOBRAMYCIN	A-S Medication Solutions	94ef5b16-4882-4994-a905-1ee617516186	2024-01-05	Warnings, Adverse reactions	Name fallback brand name: Tobramycin generic name: TOBRAMYCIN
Tobramycin	TOBRAMYCIN	Bausch & Lomb Incorporated	a5693ec9-d2f7-4d45-90b0-a113c54840d7	2023-11-01	Warnings, Adverse reactions	Name fallback brand name: Tobramycin generic name: TOBRAMYCIN
Tobramycin	TOBRAMYCIN	Teva Pharmaceuticals USA, Inc.	c5f65e5b-c851-45da-a0e8-215d9a4e6ad3	2023-10-31	Warnings, Adverse reactions	Name fallback brand name: Tobramycin generic name: TOBRAMYCIN
Tobramycin	TOBRAMYCIN	Amneal Pharmaceuticals LLC	15f9c0cd-7dbf-4a91-9961-14f1dd000343	2023-05-30	Warnings, Adverse reactions	Name fallback brand name: Tobramycin generic name: TOBRAMYCIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.