Application 076817

Type: ANDA
Sponsor: VISTA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM	TABLET;ORAL	400MG;80MG	No	No
002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM	TABLET;ORAL	800MG;160MG	No	No

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

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
A076817-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB		2005-10-07
A076817-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB		2005-10-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A076817-001	AB
A076817-002	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 3 · 84 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	A076817-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076817-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-10-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076817-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076817-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-10-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076817-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076817-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-10-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076817-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-10-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076817-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-10-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076817-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-10-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076817-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-10-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076817-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-10-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076817-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-10-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076817-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-10-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076817-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-10-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076817-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-10-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076817-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-10-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076817-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-10-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076817-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-10-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076817-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-10-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076817-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-10-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076817-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-10-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076817-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-10-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076817-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-10-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076817-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-10-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076817-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-10-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076817-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-10-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076817-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-10-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076817-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-10-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076817-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-10-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076817-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-10-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076817-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-10-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076817-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-10-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076817-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-10-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076817-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-10-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076817-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-10-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076817-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-10-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076817-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-10-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076817-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-10-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076817-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-10-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076817-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-10-07	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A076817-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076817-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076817-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076817-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076817-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076817-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076817-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076817-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076817-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076817-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076817-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076817-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076817-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076817-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076817-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076817-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076817-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076817-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076817-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076817-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076817-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076817-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076817-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076817-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076817-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076817-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076817-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076817-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076817-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076817-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076817-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076817-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076817-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076817-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076817-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076817-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076817-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076817-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076817-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076817-002	AB	1	`bb7c543d1eb4…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Proficient Rx LP	c407381f-3d8e-4fdf-9132-cd3968099296	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076817 application number: ANDA076817 ndc (product): 63187-008
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Vista Pharmaceuticals, Inc.	3edca473-8fdc-462a-b378-6c3279503a70	2020-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076817 application number: ANDA076817 ndc (product): 61971-120 ndc (product): 61971-115

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10544-926	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	Blenheim Pharmacal, Inc.	ANDA	Current
50090-2348	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	A-S Medication Solutions	ANDA	Current
50090-2348	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	A-S Medication Solutions	ANDA	Current
51655-111	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	Northwind Pharmaceuticals	ANDA	Current
61919-766	SULFAMETHOXAZOLE AND TRIMETHOPRIM	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Direct Rx	ANDA	Current
61971-115	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	Vista Pharmaceuticals, Inc.	ANDA	Current
61971-115	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	Vista Pharmaceuticals, Inc.	ANDA	Current
61971-120	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	Vista Pharmaceuticals, Inc.	ANDA	Current
61971-120	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	Vista Pharmaceuticals, Inc.	ANDA	Current
63187-008	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	Proficient Rx LP	ANDA	Current
63187-008	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	Proficient Rx LP	ANDA	Current
63187-008	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	Proficient Rx LP	ANDA	Current
67296-0724	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	RedPharm Drug, Inc.	ANDA	Current
67296-0724	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	RedPharm Drug, Inc.	ANDA	Current
67296-0724	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	RedPharm Drug, Inc.	ANDA	Current
68071-3033	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3033	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	NuCare Pharmaceuticals, Inc.	ANDA	Current
68788-9500	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	Preferred Pharmaceuticals	ANDA	Current
68788-9500	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	Preferred Pharmaceuticals, Inc.	ANDA	Current
70934-302	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-302	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-302	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current