FDA.reportPublic FDA data

Application 018598

Type
NDA
Sponsor
FOSUN PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
003SULFAMETHOXAZOLE AND TRIMETHOPRIMSULFAMETHOXAZOLE; TRIMETHOPRIMTABLET;ORAL400MG;80MGNoNo
004SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTHSULFAMETHOXAZOLE; TRIMETHOPRIMTABLET;ORAL800MG;160MGNoNo

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
N018598-003SULFAMETHOXAZOLE AND TRIMETHOPRIMSULFAMETHOXAZOLE; TRIMETHOPRIM400MG;80MGTABLET / ORAL1982-05-19
N018598-004SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTHSULFAMETHOXAZOLE; TRIMETHOPRIM800MG;160MGTABLET / ORAL1982-05-19

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 22:38:342026-08N018598-003SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORAL1982-05-1984e616aacf4f…
2026-09-14 22:38:342026-08N018598-004SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH800MG;160MGTABLET / ORAL1982-05-1984e616aacf4f…
2026-08-18 06:07:402026-07N018598-003SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORAL1982-05-19caaa826d4ba7…
2026-08-18 06:07:402026-07N018598-004SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH800MG;160MGTABLET / ORAL1982-05-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018598-003SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORAL1982-05-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018598-004SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH800MG;160MGTABLET / ORAL1982-05-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018598-003SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORAL1982-05-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018598-004SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH800MG;160MGTABLET / ORAL1982-05-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08N018598-003SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORAL1982-05-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018598-004SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH800MG;160MGTABLET / ORAL1982-05-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018598-003SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORAL1982-05-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018598-004SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH800MG;160MGTABLET / ORAL1982-05-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018598-003SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORAL1982-05-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018598-004SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH800MG;160MGTABLET / ORAL1982-05-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018598-003SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORAL1982-05-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018598-004SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH800MG;160MGTABLET / ORAL1982-05-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018598-003SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORAL1982-05-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018598-004SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH800MG;160MGTABLET / ORAL1982-05-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018598-003SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORAL1982-05-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018598-004SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH800MG;160MGTABLET / ORAL1982-05-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018598-003SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORAL1982-05-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018598-004SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH800MG;160MGTABLET / ORAL1982-05-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018598-003SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORAL1982-05-19d06236e962d9…
2024-10-29 15:01 UTC2024-10N018598-004SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH800MG;160MGTABLET / ORAL1982-05-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018598-003SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORAL1982-05-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018598-004SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH800MG;160MGTABLET / ORAL1982-05-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018598-003SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORAL1982-05-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018598-004SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH800MG;160MGTABLET / ORAL1982-05-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018598-003SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORAL1982-05-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018598-004SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH800MG;160MGTABLET / ORAL1982-05-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018598-003SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORAL1982-05-198072bd15b7f6…
2024-05-31 18:47 UTC2024-05N018598-004SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH800MG;160MGTABLET / ORAL1982-05-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018598-003SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORAL1982-05-195c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018598-004SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH800MG;160MGTABLET / ORAL1982-05-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018598-003SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORAL1982-05-195d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N018598-004SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH800MG;160MGTABLET / ORAL1982-05-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018598-003SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORAL1982-05-194b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N018598-004SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH800MG;160MGTABLET / ORAL1982-05-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018598-003SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORAL1982-05-1974a2ff9319b5…
2019-12-13 00:20 UTC2019-12N018598-004SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH800MG;160MGTABLET / ORAL1982-05-1974a2ff9319b5…

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.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81352SUPPL 2025-02-25
81327SUPPL 2025-02-24
78895SUPPL 2024-06-25
78889SUPPL 2024-06-25
69019SUPPL2021-10-19
69013SUPPL2021-10-18
59933SUPPL2019-09-06
59927SUPPL2019-09-06