Application 090828

Type
ANDA
Sponsor
GLENMARK GENERICS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SULFAMETHOXAZOLE AND TRIMETHOPRIMSULFAMETHOXAZOLE; TRIMETHOPRIMTABLET;ORAL800MG;160MGNoNo
002SULFAMETHOXAZOLE AND TRIMETHOPRIMSULFAMETHOXAZOLE; TRIMETHOPRIMTABLET;ORAL400MG;80MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090828-001SULFAMETHOXAZOLE AND TRIMETHOPRIMSULFAMETHOXAZOLE; TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-12-22
A090828-002SULFAMETHOXAZOLE AND TRIMETHOPRIMSULFAMETHOXAZOLE; TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-12-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A090828-001AB
A090828-002AB

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090828-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-12-2284e616aacf4f…
2026-09-14 22:38:342026-08A090828-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-12-2284e616aacf4f…
2026-08-18 06:07:402026-07A090828-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-12-22caaa826d4ba7…
2026-08-18 06:07:402026-07A090828-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-12-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090828-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-12-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090828-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-12-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090828-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-12-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090828-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-12-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A090828-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-12-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090828-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-12-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090828-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-12-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090828-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-12-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090828-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-12-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090828-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-12-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090828-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-12-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090828-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-12-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090828-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-12-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090828-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-12-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090828-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-12-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090828-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-12-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090828-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-12-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090828-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-12-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090828-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-12-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A090828-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-12-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090828-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-12-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090828-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-12-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090828-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-12-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090828-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-12-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090828-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-12-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090828-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-12-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090828-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-12-228072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090828-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-12-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090828-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-12-225c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090828-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-12-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090828-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-12-225d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090828-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-12-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090828-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-12-224b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090828-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-12-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090828-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-12-2274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090828-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-12-2274a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A090828-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A090828-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A090828-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090828-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090828-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090828-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090828-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090828-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090828-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090828-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090828-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090828-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090828-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090828-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090828-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090828-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090828-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090828-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090828-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090828-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090828-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090828-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090828-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090828-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090828-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090828-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090828-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090828-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090828-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090828-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090828-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090828-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090828-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090828-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090828-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090828-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090828-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090828-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090828-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090828-002AB174a2ff9319b5…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMCronus Pharma LLC1b5de94f-973a-4b5a-91d7-45e05be786502025-04-02Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMRising Pharma Holdings, Inc.e1a3748d-ca73-4e56-95ad-d25189cc346e2025-04-02Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutions62616708-a538-459f-9b7f-ed90c6aa5fc62025-04-01Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutions14767ff8-7803-4922-ac03-ff80c061e5ba2025-03-31Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutionsfd90d8bd-1b84-4347-a98a-f8f94746f3e42025-03-31Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutions4e12b7e1-fa2f-4cd1-ada6-19a7d56523482025-03-31Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMChartwell RX, LLCb5b7aba5-f93d-46bc-a3c2-712de1c5cff32025-03-28Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMPD-Rx Pharmaceuticals, Inc.3ef62512-0dc3-4821-9b60-6b375841c4c02025-03-26Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMAurobindo Pharma Limited284b5dac-2b8d-46bf-95fe-80ce03fa178a2025-03-12Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutions8c74ea5c-d05e-4fc1-b980-aacaab56d4722025-02-26Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutions20054147-811c-471a-8ec4-1b2903fe906e2025-02-26Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutionsa12fb7b0-9ff5-48f1-8fd9-4fbdfdbe09bc2025-02-26Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMAmneal Pharmaceuticals of New York LLC3233c54d-484d-4550-b172-db8af47d1b7f2025-02-26Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMQuality Care Products LLC079c828c-148f-45b9-966e-d8906043b2a22024-12-17Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMAurobindo Pharma Limiteda6182855-6287-45e9-b6b4-7b57efc9c76e2024-12-02Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMPrasco Laboratories6111a3c9-1406-4337-8b55-0f33120af8192024-11-18Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutions7d7ca48b-8655-4cfb-8db0-28eddf1feb9b2024-10-25Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMBryant Ranch Prepacka174991a-53e7-c791-3cee-b706a48e0ec52024-10-09Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMBryant Ranch Prepack27bebe39-c069-4a9d-99d1-c7cf44ac2f412024-10-07Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMNuCare Pharmaceuticals, Inc.3ed6bf70-2841-04f8-e054-00144ff8d46c2024-08-14Warnings, Adverse reactionsName 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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-092Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimBlenheim Pharmacal, Inc.ANDACurrent
53808-0981Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimState of Florida DOH Central PharmacyANDACurrent
67046-714Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimContract Pharmacy Services-PAANDACurrent
68462-339Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimGlenmark Generics Inc. USAANDACurrent
68462-340Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimGlenmark Generics Inc. USAANDACurrent