Application 063100

Type: ANDA
Sponsor: TEVA PHARMS USA

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 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
A063100-001	TOBRAMYCIN SULFATE	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION			1992-01-30

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 · 42 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
2026-08-18 06:07:40	2026-07	A063100-001	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION		1992-01-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A063100-001	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION		1992-01-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A063100-001	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION		1992-01-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A063100-001	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION		1992-01-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A063100-001	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION		1992-01-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A063100-001	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION		1992-01-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A063100-001	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION		1992-01-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A063100-001	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION		1992-01-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A063100-001	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION		1992-01-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A063100-001	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION		1992-01-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A063100-001	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION		1992-01-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A063100-001	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION		1992-01-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A063100-001	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION		1992-01-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A063100-001	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION		1992-01-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A063100-001	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION		1992-01-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A063100-001	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1992-01-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A063100-001	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1992-01-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A063100-001	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1992-01-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A063100-001	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1992-01-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A063100-001	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1992-01-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A063100-001	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1992-01-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A063100-001	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1992-01-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A063100-001	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1992-01-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A063100-001	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1992-01-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A063100-001	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1992-01-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A063100-001	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1992-01-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A063100-001	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1992-01-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A063100-001	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1992-01-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A063100-001	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION		1992-01-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A063100-001	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION		1992-01-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A063100-001	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION		1992-01-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A063100-001	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION		1992-01-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A063100-001	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION		1992-01-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A063100-001	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION		1992-01-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A063100-001	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION		1992-01-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A063100-001	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION		1992-01-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A063100-001	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION		1992-01-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A063100-001	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1992-01-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A063100-001	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1992-01-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A063100-001	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1992-01-30	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A063100-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A063100-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A063100-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A063100-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A063100-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A063100-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A063100-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A063100-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A063100-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A063100-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A063100-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A063100-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A063100-001	AP	1	`ea99ee380514…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A063100-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A063100-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A063100-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A063100-001	AP	1	`cb3db0bc1861…`

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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0703-9402	Tobramycin	Tobramycin	Teva Parenteral Medicines, Inc.	ANDA	Current