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 3 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	Cronus Pharma LLC	1b5de94f-973a-4b5a-91d7-45e05be78650	2025-04-02	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Rising Pharma Holdings, Inc.	e1a3748d-ca73-4e56-95ad-d25189cc346e	2025-04-02	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	62616708-a538-459f-9b7f-ed90c6aa5fc6	2025-04-01	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	14767ff8-7803-4922-ac03-ff80c061e5ba	2025-03-31	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	fd90d8bd-1b84-4347-a98a-f8f94746f3e4	2025-03-31	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	4e12b7e1-fa2f-4cd1-ada6-19a7d5652348	2025-03-31	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Chartwell RX, LLC	b5b7aba5-f93d-46bc-a3c2-712de1c5cff3	2025-03-28	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	PD-Rx Pharmaceuticals, Inc.	3ef62512-0dc3-4821-9b60-6b375841c4c0	2025-03-26	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Aurobindo Pharma Limited	284b5dac-2b8d-46bf-95fe-80ce03fa178a	2025-03-12	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	8c74ea5c-d05e-4fc1-b980-aacaab56d472	2025-02-26	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	20054147-811c-471a-8ec4-1b2903fe906e	2025-02-26	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	a12fb7b0-9ff5-48f1-8fd9-4fbdfdbe09bc	2025-02-26	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Amneal Pharmaceuticals of New York LLC	3233c54d-484d-4550-b172-db8af47d1b7f	2025-02-26	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Quality Care Products LLC	079c828c-148f-45b9-966e-d8906043b2a2	2024-12-17	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Aurobindo Pharma Limited	a6182855-6287-45e9-b6b4-7b57efc9c76e	2024-12-02	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Prasco Laboratories	6111a3c9-1406-4337-8b55-0f33120af819	2024-11-18	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	7d7ca48b-8655-4cfb-8db0-28eddf1feb9b	2024-10-25	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Bryant Ranch Prepack	a174991a-53e7-c791-3cee-b706a48e0ec5	2024-10-09	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Bryant Ranch Prepack	27bebe39-c069-4a9d-99d1-c7cf44ac2f41	2024-10-07	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	NuCare Pharmaceuticals, Inc.	3ed6bf70-2841-04f8-e054-00144ff8d46c	2024-08-14	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