Application 017952

Type: NDA
Sponsor: ROCHE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRIMPEX	TRIMETHOPRIM	TABLET;ORAL	100MG	No	No
002	TRIMPEX 200	TRIMETHOPRIM	TABLET;ORAL	200MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N017952-001	TRIMPEX	TRIMETHOPRIM	100MG	TABLET / ORAL		Approved before 1982
N017952-002	TRIMPEX 200	TRIMETHOPRIM	200MG	TABLET / ORAL			1982-11-09

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N017952-001	TRIMPEX	100MG	TABLET / ORAL	Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N017952-002	TRIMPEX 200	200MG	TABLET / ORAL		1982-11-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017952-001	TRIMPEX	100MG	TABLET / ORAL	Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N017952-002	TRIMPEX 200	200MG	TABLET / ORAL		1982-11-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017952-001	TRIMPEX	100MG	TABLET / ORAL	Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N017952-002	TRIMPEX 200	200MG	TABLET / ORAL		1982-11-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017952-001	TRIMPEX	100MG	TABLET / ORAL	Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017952-002	TRIMPEX 200	200MG	TABLET / ORAL		1982-11-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017952-001	TRIMPEX	100MG	TABLET / ORAL	Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N017952-002	TRIMPEX 200	200MG	TABLET / ORAL		1982-11-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017952-001	TRIMPEX	100MG	TABLET / ORAL	Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N017952-002	TRIMPEX 200	200MG	TABLET / ORAL		1982-11-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017952-001	TRIMPEX	100MG	TABLET / ORAL	Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N017952-002	TRIMPEX 200	200MG	TABLET / ORAL		1982-11-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017952-001	TRIMPEX	100MG	TABLET / ORAL	Approved before 1982		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N017952-002	TRIMPEX 200	200MG	TABLET / ORAL		1982-11-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017952-001	TRIMPEX	100MG	TABLET / ORAL	Approved before 1982		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N017952-002	TRIMPEX 200	200MG	TABLET / ORAL		1982-11-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017952-001	TRIMPEX	100MG	TABLET / ORAL	Approved before 1982		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N017952-002	TRIMPEX 200	200MG	TABLET / ORAL		1982-11-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017952-001	TRIMPEX	100MG	TABLET / ORAL	Approved before 1982		`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017952-002	TRIMPEX 200	200MG	TABLET / ORAL		1982-11-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017952-001	TRIMPEX	100MG	TABLET / ORAL	Approved before 1982		`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N017952-002	TRIMPEX 200	200MG	TABLET / ORAL		1982-11-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017952-001	TRIMPEX	100MG	TABLET / ORAL	Approved before 1982		`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N017952-002	TRIMPEX 200	200MG	TABLET / ORAL		1982-11-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017952-001	TRIMPEX	100MG	TABLET / ORAL	Approved before 1982		`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017952-002	TRIMPEX 200	200MG	TABLET / ORAL		1982-11-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017952-001	TRIMPEX	100MG	TABLET / ORAL	Approved before 1982		`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017952-002	TRIMPEX 200	200MG	TABLET / ORAL		1982-11-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017952-001	TRIMPEX	100MG	TABLET / ORAL	Approved before 1982		`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017952-002	TRIMPEX 200	200MG	TABLET / ORAL		1982-11-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017952-001	TRIMPEX	100MG	TABLET / ORAL	Approved before 1982		`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017952-002	TRIMPEX 200	200MG	TABLET / ORAL		1982-11-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017952-001	TRIMPEX	100MG	TABLET / ORAL	Approved before 1982		`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N017952-002	TRIMPEX 200	200MG	TABLET / ORAL		1982-11-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017952-001	TRIMPEX	100MG	TABLET / ORAL	Approved before 1982		`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N017952-002	TRIMPEX 200	200MG	TABLET / ORAL		1982-11-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017952-001	TRIMPEX	100MG	TABLET / ORAL	Approved before 1982		`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017952-002	TRIMPEX 200	200MG	TABLET / ORAL		1982-11-09	`3a93d1ddd44b…`

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 generic name: TRIMETHOPRIM
Trimethoprim	TRIMETHOPRIM	Dr. Reddy's Labratories Inc.	73ccebc1-7412-2424-d62c-a5180ec52d81	2024-01-26	Warnings, Adverse reactions	Name fallback generic name: TRIMETHOPRIM
Trimethoprim	TRIMETHOPRIM	Golden State Medical Supply, Inc.	f756f4be-3cda-ab98-e053-6294a90a1424	2023-03-20	Warnings, Adverse reactions	Name fallback generic name: TRIMETHOPRIM
Trimethoprim	TRIMETHOPRIM	Novitium Pharma LLC	95a1572c-6109-4d1f-bf92-262015a7654e	2022-08-02	Warnings, Adverse reactions	Name fallback generic name: TRIMETHOPRIM
Trimethoprim	TRIMETHOPRIM	Novel Laboratories, Inc.	b27e43b5-670b-43f6-b28b-413e54f914da	2017-06-21	Warnings, Adverse reactions	Name fallback generic name: TRIMETHOPRIM

Reported adverse events (FAERS/openFDA)#

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