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 3 of 3 · 58 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tobramycin	TOBRAMYCIN	A-S Medication Solutions	774b608b-d6d9-4349-8772-11c69897be42	2023-05-23	Warnings, Adverse reactions	Name fallback brand name: Tobramycin generic name: TOBRAMYCIN
TOBRAMYCIN	TOBRAMYCIN	Aurobindo Pharma Limited	0aa5859e-cd80-49c0-881b-47f39d1f1d01	2023-05-18	Warnings, Adverse reactions	Name fallback brand name: TOBRAMYCIN generic name: TOBRAMYCIN
Tobramycin	TOBRAMYCIN	Sun Pharmaceutical Industries, Inc.	c452e428-0d8f-4f35-b98f-5aa3b814cb49	2023-04-27	Warnings, Adverse reactions	Name fallback brand name: Tobramycin generic name: TOBRAMYCIN
Tobramycin	TOBRAMYCIN	Baxter Healthcare Corporation	a9897444-71f6-42af-9b71-4aa77829ade0	2023-03-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tobramycin generic name: TOBRAMYCIN
Tobramycin	TOBRAMYCIN	Lifestar Pharma LLC	96517b44-55df-4d2c-8fe8-110ed51dfafe	2023-03-10	Warnings, Adverse reactions	Name fallback brand name: Tobramycin generic name: TOBRAMYCIN
Tobramycin	TOBRAMYCIN	Gland Pharma Limited	645d34d9-275d-428e-863d-ae15ad009c44	2023-03-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tobramycin generic name: TOBRAMYCIN
Tobramycin	TOBRAMYCIN	Gland Pharma Limited	02b48684-168c-4cd9-8375-794206eff23e	2023-02-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tobramycin generic name: TOBRAMYCIN
BETHKIS	TOBRAMYCIN	Chiesi USA, Inc.	1cd3d47b-025f-4705-9daf-cf07725ec223	2023-02-24	Warnings, Adverse reactions	Name fallback generic name: TOBRAMYCIN
Tobramycin	TOBRAMYCIN	Fosun Pharma USA Inc	c4751a4f-c9c1-60c5-e053-2995a90aeba9	2022-12-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tobramycin generic name: TOBRAMYCIN
Tobramycin	TOBRAMYCIN	Mylan Institutional LLC	ac8134d9-a726-4508-b8b9-a536ef17243d	2022-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tobramycin generic name: TOBRAMYCIN
Tobramycin	TOBRAMYCIN	Gland Pharma Limited	38219f34-4859-428f-9ec1-06ead7604211	2022-10-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tobramycin generic name: TOBRAMYCIN
Tobramycin	TOBRAMYCIN	Proficient Rx LP	d8235017-cb52-44d4-a6e6-6ee3f00c47d2	2022-07-01	Warnings, Adverse reactions	Name fallback brand name: Tobramycin generic name: TOBRAMYCIN
Tobramycin	TOBRAMYCIN	Proficient Rx LP	2f95ece0-62f7-47f4-b7ab-90f95fa3dc27	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: Tobramycin generic name: TOBRAMYCIN
Tobramycin	TOBRAMYCIN	Sandoz Inc	27e2c16e-19b0-4745-93eb-5cf99f94bb92	2021-08-31	Warnings, Adverse reactions	Name fallback brand name: Tobramycin generic name: TOBRAMYCIN
Tobramycin	TOBRAMYCIN	Gland Pharma Limited	f8c92d73-711a-423f-bf34-bdec4464828e	2021-07-27	Warnings, Adverse reactions	Name fallback brand name: Tobramycin generic name: TOBRAMYCIN
Tobramycin	TOBRAMYCIN	Asclemed USA, Inc.	5564e780-2320-4ce7-b211-806ca99110c3	2020-10-24	Warnings, Adverse reactions	Name fallback brand name: Tobramycin generic name: TOBRAMYCIN
Tobramycin	TOBRAMYCIN	Proficient Rx LP	4eb4dfd1-f3ae-4400-b043-910b4c77296b	2019-11-01	Warnings, Adverse reactions	Name fallback brand name: Tobramycin generic name: TOBRAMYCIN
Tobramycin	TOBRAMYCIN	Proficient Rx LP	ac497300-eb1e-4021-b504-89f19e1eb0f3	2019-11-01	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.