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 42.

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2022-03-09 01:35 UTC2022-03A090828-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-12-22bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090828-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-12-22bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2022-03-09 01:35 UTC2022-03A090828-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090828-002AB1bb7c543d1eb4…

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 · 78 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMREMEDYREPACK INC.ce44959b-4bfe-4ba9-9fc2-7f9d4663d5422026-08-10Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMCardinal Health 107, LLC5dc03027-cdaf-461f-87fd-630d382fc7232026-08-07Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMREMEDYREPACK INC.ec2e335c-3357-40d8-9615-a09fc40ce5f42026-08-07Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMREMEDYREPACK INC.c45ac3a4-d397-486e-abd1-3499165430682026-07-27Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMCardinal Health 107, LLC08500fcb-dbec-4ac2-91c3-189d27907ec02026-07-17Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMUnit Dose Solutions, Inc.562e2547-db2d-e2d2-e063-6294a90a1f5d2026-07-09Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMSt. Mary's Medical Park Pharmacye3a49508-0ebe-1334-e053-2a95a90ae1732026-06-11Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMCoupler LLC518cc045-a12b-f08f-e063-6394a90acb0c2026-05-11Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMANI Pharmaceuticals, Inc.5ff03694-787a-409d-a95e-8422aa27499c2026-04-06Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMAmneal Pharmaceuticals LLCf0e73842-6002-43c2-97fc-0cadc1bf63462026-04-02Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutions69af86b4-9c9f-4a70-b448-97b36698f3cd2026-03-26Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMAvPAK29df8839-3dfa-0b2b-c5a3-906db6997b3b2026-03-24Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutions75b9d194-b960-4943-bedc-96e3d65c4da92026-03-03Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMChartwell Governmental & Specialty RX, LLC.2a5173ba-047d-4a80-81fb-7154265ae3d12026-02-24Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMAvKARE9f130443-c8e7-9122-8f27-f72f07f3f29e2026-02-10Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMNuCare Pharmaceuticals,Inc.7f82e5e0-b627-a3f3-e053-2991aa0abaa52026-02-09Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMSportpharm LLC52304e5e-d097-48f2-8b64-210908e4eb542026-02-03Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMREMEDYREPACK INC.99e1ace6-7665-4f87-82fd-5e7c4989e0982026-01-13Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMNuCare Pharmaceuticals,Inc.8c3e4738-0e0a-a854-e053-2995a90a7d712026-01-05Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMNorthwind Health Company, LLCf2b8e9d9-1274-22ca-e053-2a95a90a6f1a2026-01-01Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim

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