Application 212699

Type: ANDA
Sponsor: LUPIN LTD

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 43.

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
A212699-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL			2021-01-05

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A212699-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		2021-01-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212699-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		2021-01-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212699-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		2021-01-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212699-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		2021-01-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212699-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		2021-01-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212699-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		2021-01-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212699-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		2021-01-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212699-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		2021-01-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212699-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		2021-01-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212699-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		2021-01-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212699-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		2021-01-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212699-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		2021-01-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212699-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		2021-01-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212699-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		2021-01-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212699-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		2021-01-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212699-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		2021-01-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212699-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		2021-01-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212699-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2021-01-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212699-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2021-01-05	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212699-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2021-01-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212699-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2021-01-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212699-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2021-01-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212699-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2021-01-05	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212699-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		2021-01-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212699-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		2021-01-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212699-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		2021-01-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212699-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		2021-01-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212699-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		2021-01-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212699-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		2021-01-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212699-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		2021-01-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212699-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		2021-01-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212699-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		2021-01-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212699-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		2021-01-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212699-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		2021-01-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212699-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		2021-01-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212699-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		2021-01-05	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212699-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL		2021-01-05	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-08 23:34 UTC	2022-04	A212699-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212699-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212699-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212699-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212699-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212699-001	AB	1	`5aa47cf7b7d7…`

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 2 of 4 · 79 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	REMEDYREPACK INC.	99e1ace6-7665-4f87-82fd-5e7c4989e098	2026-01-13	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	NuCare Pharmaceuticals,Inc.	8c3e4738-0e0a-a854-e053-2995a90a7d71	2026-01-05	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Northwind Health Company, LLC	f2b8e9d9-1274-22ca-e053-2a95a90a6f1a	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Northwind Health Company, LLC	f7f97520-d063-ec87-e053-6294a90aae0c	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Northwind Health Company, LLC	471c5995-a4df-fbe3-e063-6394a90aa50e	2025-12-29	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	QPharma, Inc.	41529314-b203-47f4-88dd-5aa57c74985f	2025-12-02	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Major Pharmaceuticals	abe0d2d5-4879-4b4e-9b57-47ea83a17ba0	2025-11-18	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	VERITYRX, LLC	427b8040-99a4-8e81-e063-6394a90a76c5	2025-10-31	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	NuCare Pharmaceuticals,Inc.	1274cefb-0799-e2e4-e063-6394a90aad02	2025-10-07	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	American Health Packaging	7f25bff3-0e86-4bec-b293-54b68347867f	2025-07-23	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Somerset Therapeutics, LLC	ebb570bb-6e5e-489e-875c-9e7b3a6d716a	2025-07-16	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Golden State Medical Supply, Inc.	bd3161fe-23d7-458a-86a4-fb958d9c94d3	2025-06-06	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	American Health Packaging	f14b8d07-e73b-4ceb-bd6a-578c961b7c09	2025-05-16	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	0aaf1dbe-b69d-43bd-a4ab-69cb27ab417d	2025-05-15	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Kesin Pharma	31f9e720-3869-061f-e063-6294a90a43b4	2025-05-13	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Teva Parenteral Medicines, Inc.	bf7a0845-de4f-46be-841a-0faf47f8b530	2025-04-30	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	PD-Rx Pharmaceuticals, Inc.	c4da9c4f-0704-4ed5-9d19-5c949f37f726	2025-04-30	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Teva Parenteral Medicines, Inc.	b89b5502-ce87-45a6-a43c-9891da3cfca4	2025-04-30	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Teva Parenteral Medicines, Inc.	640f5b0c-748d-4a68-a1de-59cc3e00ed49	2025-04-30	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Sun Pharmaceutical Industries, Inc.	4833319a-a7b3-4bf4-bec4-6531b43182d4	2025-04-03	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70748-134	sulfamethoxazole and trimethoprim	sulfamethoxazole and trimethoprim	Lupin Pharmaceuticals, Inc.	ANDA	Current