Application 211189

Type: ANDA
Sponsor: GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TOBRAMYCIN SULFATE	TOBRAMYCIN SULFATE	INJECTABLE;INJECTION	EQ 1.2GM BASE/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A211189-001	TOBRAMYCIN SULFATE	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP		2021-05-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A211189-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211189-001	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2021-05-18	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A211189-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211189-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211189-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211189-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211189-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211189-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211189-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211189-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211189-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211189-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211189-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211189-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211189-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211189-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211189-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211189-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211189-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211189-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211189-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211189-001	AP	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211189-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211189-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211189-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211189-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211189-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211189-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211189-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211189-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211189-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211189-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211189-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211189-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211189-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211189-001	AP	1	`a50c72e98297…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tobramycin	TOBRAMYCIN	Xiromed LLC	8b50d1b5-ea8a-5844-358a-493f1965c07f	2026-02-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211189 application number: ANDA211189 ndc (product): 70700-173
Tobramycin	TOBRAMYCIN	Northstar Rx LLC	55d09ffd-4f32-8aeb-3904-8a17db635e3a	2025-09-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211189 application number: ANDA211189
Tobramycin	TOBRAMYCIN	Fosun Pharma USA Inc	c4751a4f-c9c1-60c5-e053-2995a90aeba9	2022-12-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211189 application number: ANDA211189 ndc (product): 72266-163
Tobramycin	TOBRAMYCIN	Gland Pharma Limited	38219f34-4859-428f-9ec1-06ead7604211	2022-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211189 application number: ANDA211189 ndc (product): 68083-312

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
68083-312	Tobramycin	Tobramycin	Gland Pharma Limited	ANDA	Current
68083-312	Tobramycin	Tobramycin	Gland Pharma Limited	ANDA	Current
70700-173	Tobramycin	Tobramycin	Xiromed LLC	ANDA	Current
70700-173	Tobramycin	Tobramycin	Xiromed LLC	ANDA	Current
70700-173	Tobramycin	Tobramycin	Xiromed LLC	ANDA	Current
72266-163	Tobramycin	Tobramycin	Fosun Pharma USA Inc	ANDA	Current
72266-163	Tobramycin	Tobramycin	Fosun Pharma USA Inc	ANDA	Current