Application 070049

Type: ANDA
Sponsor: WATSON LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRIMETHOPRIM	TRIMETHOPRIM	TABLET;ORAL	100MG	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
A070049-001	TRIMETHOPRIM	TRIMETHOPRIM	100MG	TABLET / ORAL	AB		1985-06-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A070049-001	AB

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A070049-001	TRIMETHOPRIM	100MG	TABLET / ORAL	AB	1985-06-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070049-001	TRIMETHOPRIM	100MG	TABLET / ORAL	AB	1985-06-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070049-001	TRIMETHOPRIM	100MG	TABLET / ORAL	AB	1985-06-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070049-001	TRIMETHOPRIM	100MG	TABLET / ORAL	AB	1985-06-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070049-001	TRIMETHOPRIM	100MG	TABLET / ORAL	AB	1985-06-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070049-001	TRIMETHOPRIM	100MG	TABLET / ORAL	AB	1985-06-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070049-001	TRIMETHOPRIM	100MG	TABLET / ORAL	AB	1985-06-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070049-001	TRIMETHOPRIM	100MG	TABLET / ORAL	AB	1985-06-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070049-001	TRIMETHOPRIM	100MG	TABLET / ORAL	AB	1985-06-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070049-001	TRIMETHOPRIM	100MG	TABLET / ORAL	AB	1985-06-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070049-001	TRIMETHOPRIM	100MG	TABLET / ORAL	AB	1985-06-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070049-001	TRIMETHOPRIM	100MG	TABLET / ORAL	AB	1985-06-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070049-001	TRIMETHOPRIM	100MG	TABLET / ORAL	AB	1985-06-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070049-001	TRIMETHOPRIM	100MG	TABLET / ORAL	AB	1985-06-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070049-001	TRIMETHOPRIM	100MG	TABLET / ORAL	AB	1985-06-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070049-001	TRIMETHOPRIM	100MG	TABLET / ORAL	AB	1985-06-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070049-001	TRIMETHOPRIM	100MG	TABLET / ORAL	AB	1985-06-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070049-001	TRIMETHOPRIM	100MG	TABLET / ORAL	AB	1985-06-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070049-001	TRIMETHOPRIM	100MG	TABLET / ORAL	AB	1985-06-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070049-001	TRIMETHOPRIM	100MG	TABLET / ORAL	AB	1985-06-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070049-001	TRIMETHOPRIM	100MG	TABLET / ORAL	AB	1985-06-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070049-001	TRIMETHOPRIM	100MG	TABLET / ORAL	AB	1985-06-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070049-001	TRIMETHOPRIM	100MG	TABLET / ORAL	AB	1985-06-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070049-001	TRIMETHOPRIM	100MG	TABLET / ORAL	AB	1985-06-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070049-001	TRIMETHOPRIM	100MG	TABLET / ORAL	AB	1985-06-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070049-001	TRIMETHOPRIM	100MG	TABLET / ORAL	AB	1985-06-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070049-001	TRIMETHOPRIM	100MG	TABLET / ORAL	AB	1985-06-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070049-001	TRIMETHOPRIM	100MG	TABLET / ORAL	AB	1985-06-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070049-001	TRIMETHOPRIM	100MG	TABLET / ORAL	AB	1985-06-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070049-001	TRIMETHOPRIM	100MG	TABLET / ORAL	AB	1985-06-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070049-001	TRIMETHOPRIM	100MG	TABLET / ORAL	AB	1985-06-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070049-001	TRIMETHOPRIM	100MG	TABLET / ORAL	AB	1985-06-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070049-001	TRIMETHOPRIM	100MG	TABLET / ORAL	AB	1985-06-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070049-001	TRIMETHOPRIM	100MG	TABLET / ORAL	AB	1985-06-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070049-001	TRIMETHOPRIM	100MG	TABLET / ORAL	AB	1985-06-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070049-001	TRIMETHOPRIM	100MG	TABLET / ORAL	AB	1985-06-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070049-001	TRIMETHOPRIM	100MG	TABLET / ORAL	AB	1985-06-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070049-001	TRIMETHOPRIM	100MG	TABLET / ORAL	AB	1985-06-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070049-001	TRIMETHOPRIM	100MG	TABLET / ORAL	AB	1985-06-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070049-001	TRIMETHOPRIM	100MG	TABLET / ORAL	AB	1985-06-06	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A070049-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070049-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070049-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070049-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070049-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070049-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070049-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070049-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070049-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070049-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070049-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070049-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070049-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070049-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070049-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070049-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070049-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070049-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070049-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070049-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070049-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070049-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070049-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070049-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070049-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070049-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070049-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070049-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070049-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070049-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070049-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070049-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070049-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070049-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070049-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070049-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070049-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070049-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070049-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070049-001	AB	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trimethoprim	TRIMETHOPRIM	Lupin Pharmaceuticals,Inc.	249e938d-f181-47c4-a082-372d65462f33	2024-06-04	Warnings, Adverse reactions	Name fallback brand name: Trimethoprim generic name: TRIMETHOPRIM
Trimethoprim	TRIMETHOPRIM	Dr. Reddy's Labratories Inc.	73ccebc1-7412-2424-d62c-a5180ec52d81	2024-01-26	Warnings, Adverse reactions	Name fallback brand name: Trimethoprim generic name: TRIMETHOPRIM
Trimethoprim	TRIMETHOPRIM	Golden State Medical Supply, Inc.	f756f4be-3cda-ab98-e053-6294a90a1424	2023-03-20	Warnings, Adverse reactions	Name fallback brand name: Trimethoprim generic name: TRIMETHOPRIM
Trimethoprim	TRIMETHOPRIM	Novitium Pharma LLC	95a1572c-6109-4d1f-bf92-262015a7654e	2022-08-02	Warnings, Adverse reactions	Name fallback brand name: Trimethoprim generic name: TRIMETHOPRIM
Trimethoprim	TRIMETHOPRIM	Novel Laboratories, Inc.	b27e43b5-670b-43f6-b28b-413e54f914da	2017-06-21	Warnings, Adverse reactions	Name fallback brand name: Trimethoprim generic name: TRIMETHOPRIM

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-5571	Trimethoprim	Trimethoprim	Actavis Pharma, Inc.	ANDA	Current
50268-775	Trimethoprim	Trimethoprim	AvPAK	ANDA	Current
55289-746	Trimethoprim	Trimethoprim	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
68151-2010	Trimethoprim	Trimethoprim	Carilion Materials Management	ANDA	Current