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 1 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	Preferred Pharmaceuticals Inc.	d60c218c-6529-4944-af0b-a9dc720f32e9	2026-09-02	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Preferred Pharmaceuticals Inc.	c6171b62-835c-465e-905e-97f70438186e	2026-09-02	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	ATLANTIC BIOLOGICALS CORP.	acc3df02-1e99-46e6-8a31-9b26261c6daa	2026-08-25	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	REMEDYREPACK INC.	ce44959b-4bfe-4ba9-9fc2-7f9d4663d542	2026-08-10	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Cardinal Health 107, LLC	5dc03027-cdaf-461f-87fd-630d382fc723	2026-08-07	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	REMEDYREPACK INC.	ec2e335c-3357-40d8-9615-a09fc40ce5f4	2026-08-07	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	REMEDYREPACK INC.	c45ac3a4-d397-486e-abd1-349916543068	2026-07-27	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Cardinal Health 107, LLC	08500fcb-dbec-4ac2-91c3-189d27907ec0	2026-07-17	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Unit Dose Solutions, Inc.	562e2547-db2d-e2d2-e063-6294a90a1f5d	2026-07-09	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	St. Mary's Medical Park Pharmacy	e3a49508-0ebe-1334-e053-2a95a90ae173	2026-06-11	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Coupler LLC	518cc045-a12b-f08f-e063-6394a90acb0c	2026-05-11	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	ANI Pharmaceuticals, Inc.	5ff03694-787a-409d-a95e-8422aa27499c	2026-04-06	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Amneal Pharmaceuticals LLC	f0e73842-6002-43c2-97fc-0cadc1bf6346	2026-04-02	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	69af86b4-9c9f-4a70-b448-97b36698f3cd	2026-03-26	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	AvPAK	29df8839-3dfa-0b2b-c5a3-906db6997b3b	2026-03-24	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	75b9d194-b960-4943-bedc-96e3d65c4da9	2026-03-03	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Chartwell Governmental & Specialty RX, LLC.	2a5173ba-047d-4a80-81fb-7154265ae3d1	2026-02-24	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	AvKARE	9f130443-c8e7-9122-8f27-f72f07f3f29e	2026-02-10	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	NuCare Pharmaceuticals,Inc.	7f82e5e0-b627-a3f3-e053-2991aa0abaa5	2026-02-09	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Sportpharm LLC	52304e5e-d097-48f2-8b64-210908e4eb54	2026-02-03	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