Application 091348

Type: ANDA
Sponsor: AUROBINDO PHARMA

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
A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	RS	2010-06-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091348-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	RS	2010-06-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	RS	2010-06-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	RS	2010-06-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	RS	2010-06-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	RS	2010-06-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	RS	2010-06-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	RS	2010-06-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	RS	2010-06-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	RS	2010-06-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	RS	2010-06-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	RS	2010-06-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	RS	2010-06-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	RS	2010-06-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	RS	2010-06-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	RS	2010-06-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091348-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2010-06-08	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A091348-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091348-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091348-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091348-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091348-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091348-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091348-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091348-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091348-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091348-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091348-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091348-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091348-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091348-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091348-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091348-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091348-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091348-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091348-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091348-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091348-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091348-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091348-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091348-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091348-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091348-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091348-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091348-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091348-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091348-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091348-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091348-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091348-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091348-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091348-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091348-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091348-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091348-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091348-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091348-001	AB	1	`e64feba35796…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	ATLANTIC BIOLOGICALS CORP.	acc3df02-1e99-46e6-8a31-9b26261c6daa	2026-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091348 application number: ANDA091348 ndc (product): 17856-0496
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	69af86b4-9c9f-4a70-b448-97b36698f3cd	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091348 application number: ANDA091348 ndc (product): 50090-0525
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	American Health Packaging	f14b8d07-e73b-4ceb-bd6a-578c961b7c09	2025-05-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091348 application number: ANDA091348
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Aurobindo Pharma Limited	a6182855-6287-45e9-b6b4-7b57efc9c76e	2024-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091348 application number: ANDA091348 ndc (product): 65862-496

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17856-0496	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
17856-0496	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
17856-0496	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
17856-0496	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
50090-0525	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	A-S Medication Solutions	ANDA	Current
65862-496	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	Aurobindo Pharma Limited	ANDA	Current
65862-496	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	Aurobindo Pharma Limited	ANDA	Current
65862-496	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	Aurobindo Pharma Limited	ANDA	Current
65862-496	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	Aurobindo Pharma Limited	ANDA	Current
65862-496	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	Aurobindo Pharma Limited	ANDA	Current
65862-496	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	Aurobindo Pharma Limited	ANDA	Current
67296-1129	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	RedPharm Drug, Inc.	ANDA	Current
67296-1129	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	RedPharm Drug, Inc.	ANDA	Current
67296-1129	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	RedPharm Drug, Inc.	ANDA	Current
68788-9512	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	Preferred Pharmaceuticals	ANDA	Current
70518-2083	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	REMEDYREPACK INC.	ANDA	Current
70518-2083	Sulfamethoxazole and Trimethoprim	Sulfamethoxazole and Trimethoprim	REMEDYREPACK INC.	ANDA	Current