Application 077612

Type: ANDA
Sponsor: ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM	SUSPENSION;ORAL	200MG/5ML;40MG/5ML	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
A077612-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	AB		2006-11-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077612-001	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 · 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	A077612-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	AB	2006-11-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077612-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	AB	2006-11-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077612-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	AB	2006-11-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077612-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	AB	2006-11-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077612-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	AB	2006-11-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077612-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	AB	2006-11-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077612-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	AB	2006-11-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077612-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	AB	2006-11-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077612-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	AB	2006-11-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077612-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	AB	2006-11-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077612-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	AB	2006-11-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077612-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	AB	2006-11-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077612-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	AB	2006-11-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077612-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	AB	2006-11-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077612-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	AB	2006-11-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077612-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	AB	2006-11-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077612-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2006-11-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077612-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2006-11-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077612-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION / ORAL	AB	2006-11-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077612-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	AB	2006-11-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077612-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION / ORAL	AB	2006-11-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077612-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION / ORAL	AB	2006-11-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077612-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION / ORAL	AB	2006-11-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077612-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION / ORAL	AB	2006-11-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077612-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION / ORAL	AB	2006-11-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077612-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION / ORAL	AB	2006-11-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077612-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION / ORAL		2006-11-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077612-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION / ORAL		2006-11-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077612-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	AB	2006-11-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077612-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	AB	2006-11-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077612-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	AB	2006-11-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077612-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	AB	2006-11-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077612-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	AB	2006-11-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077612-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	AB	2006-11-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077612-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	AB	2006-11-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077612-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	AB	2006-11-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077612-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	AB	2006-11-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077612-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	AB	2006-11-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077612-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	AB	2006-11-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077612-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	AB	2006-11-13	`e64feba35796…`

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	A077612-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077612-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077612-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077612-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077612-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077612-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077612-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077612-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077612-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077612-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077612-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077612-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077612-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077612-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077612-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077612-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077612-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077612-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077612-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077612-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077612-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077612-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077612-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077612-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077612-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077612-001	AB	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077612-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077612-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077612-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077612-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077612-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077612-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077612-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077612-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077612-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077612-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077612-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077612-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077612-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A077612-001	AB	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 · 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	Kesin Pharma	31f9e720-3869-061f-e063-6294a90a43b4	2025-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077612 application number: ANDA077612
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Prasco Laboratories	6111a3c9-1406-4337-8b55-0f33120af819	2024-11-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077612 application number: ANDA077612 ndc (product): 66993-727

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0121-4793	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	Pharmaceutical Associates, Inc.	ANDA	Current
62559-550	Sulfamethoxazole and Trimethoprim	sulfamethoxazole and trimethoprim	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-550	Sulfamethoxazole and Trimethoprim	sulfamethoxazole and trimethoprim	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-550	Sulfamethoxazole and Trimethoprim	sulfamethoxazole and trimethoprim	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-550	Sulfamethoxazole and Trimethoprim	sulfamethoxazole and trimethoprim	ANI Pharmaceuticals, Inc.	ANDA	Current
63629-1969	Sulfamethoxazole and Trimethoprim	sulfamethoxazole and trimethoprim	Bryant Ranch Prepack	ANDA	Current
63629-1969	Sulfamethoxazole and Trimethoprim	sulfamethoxazole and trimethoprim	Bryant Ranch Prepack	ANDA	Current
63629-1969	Sulfamethoxazole and Trimethoprim	sulfamethoxazole and trimethoprim	Bryant Ranch Prepack	ANDA	Current
66993-727	Sulfamethoxazole and Trimethoprim	sulfamethoxazole and trimethoprim	Prasco Laboratories	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
39536	SUPPL	2014-02-06