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 4 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	NuCare Pharmaceuticals, Inc.	46dc8f62-e700-50e3-e054-00144ff8d46c	2024-08-14	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	PAI Holdings, LLC dba PAI Pharma	777da85a-a776-4681-976d-326ec421cfc9	2024-08-01	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Pharmasource Meds, LLC	f564a029-4b20-301a-e053-2995a90adcc0	2024-05-28	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	NCS HealthCare of KY, LLC dba Vangard Labs	c2307cc2-43ee-4319-ad58-d1d28a95e5aa	2024-02-05	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Chartwell RX, LLC	e4a7572f-b372-40eb-963f-919ac100b7a8	2024-01-31	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	f39a4c93-0a0e-4801-aecc-c55a2fa5e68b	2024-01-08	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	ffc5d594-429c-4303-b3b6-f5a83e915b55	2024-01-08	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	07a49665-fe2a-4a92-a57e-49db224b012e	2024-01-08	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	8661e318-ddf3-4a60-8781-6fa42307c60a	2024-01-08	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	b85a58a7-74d6-4629-8027-0cdcbb5c815a	2023-12-17	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	07da67b1-b50c-4471-8cde-8a119eb8c935	2023-12-15	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Proficient Rx LP	befcc5b0-04bb-4211-b3dd-88f400c7fa78	2023-08-01	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	d8239804-d234-491b-965d-89a7796a5e4d	2023-02-04	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	a12bf393-d8ef-48df-e053-2a95a90a1af1	2023-01-01	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Proficient Rx LP	c407381f-3d8e-4fdf-9132-cd3968099296	2022-10-01	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Proficient Rx LP	29e83667-8d4a-49b7-9182-653cbfb2dee7	2022-05-02	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Asclemed USA, Inc.	e6c0f80a-ba22-4690-aaf8-48a4602b6831	2020-09-04	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Vista Pharmaceuticals, Inc.	3edca473-8fdc-462a-b378-6c3279503a70	2020-01-22	Warnings, Adverse reactions	Name fallback brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Proficient Rx LP	0df74ba1-1aa6-467c-92e7-6b017c7c6bce	2019-11-01	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