Application 074650

Type
ANDA
Sponsor
HI TECH PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SULFAMETHOXAZOLE AND TRIMETHOPRIMSULFAMETHOXAZOLE; TRIMETHOPRIMSUSPENSION;ORAL200MG/5ML;40MG/5MLNoYes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074650-001SULFAMETHOXAZOLE AND TRIMETHOPRIMSULFAMETHOXAZOLE; TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1997-12-29

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 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A074650-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1997-12-2984e616aacf4f…
2026-08-18 06:07:402026-07A074650-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1997-12-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074650-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1997-12-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074650-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1997-12-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A074650-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1997-12-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074650-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1997-12-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074650-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1997-12-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074650-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1997-12-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074650-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1997-12-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074650-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1997-12-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074650-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1997-12-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074650-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1997-12-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074650-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1997-12-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074650-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1997-12-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074650-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1997-12-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074650-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1997-12-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074650-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALABRS1997-12-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074650-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALABRS1997-12-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074650-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALABRS1997-12-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074650-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALABRS1997-12-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074650-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALABRS1997-12-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074650-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALABRS1997-12-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074650-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALABRS1997-12-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A074650-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALABRS1997-12-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074650-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALABRS1997-12-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074650-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALABRS1997-12-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074650-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALABRS1997-12-293f01610625f2…
2019-09-15 20:21 UTC2019-09A074650-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALABRS1997-12-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A074650-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALABRS1997-12-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074650-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALABRS1997-12-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074650-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALABRS1997-12-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074650-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALABRS1997-12-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074650-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALABRS1997-12-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074650-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALABRS1997-12-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074650-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALABRS1997-12-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074650-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALABRS1997-12-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A074650-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALABRS1997-12-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A074650-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALABRS1997-12-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074650-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALABRS1997-12-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074650-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALABRS1997-12-29f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074650-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074650-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074650-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074650-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074650-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074650-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074650-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A074650-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074650-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074650-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074650-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A074650-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A074650-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074650-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074650-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074650-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074650-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074650-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074650-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074650-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A074650-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A074650-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074650-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074650-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074650-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074650-001AB1cb3db0bc1861…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMNuCare Pharmaceuticals, Inc.46dc8f62-e700-50e3-e054-00144ff8d46c2024-08-14Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMPAI Holdings, LLC dba PAI Pharma777da85a-a776-4681-976d-326ec421cfc92024-08-01Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMPharmasource Meds, LLCf564a029-4b20-301a-e053-2995a90adcc02024-05-28Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMNCS HealthCare of KY, LLC dba Vangard Labsc2307cc2-43ee-4319-ad58-d1d28a95e5aa2024-02-05Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMChartwell RX, LLCe4a7572f-b372-40eb-963f-919ac100b7a82024-01-31Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutionsf39a4c93-0a0e-4801-aecc-c55a2fa5e68b2024-01-08Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutionsffc5d594-429c-4303-b3b6-f5a83e915b552024-01-08Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutions07a49665-fe2a-4a92-a57e-49db224b012e2024-01-08Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutions8661e318-ddf3-4a60-8781-6fa42307c60a2024-01-08Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutionsb85a58a7-74d6-4629-8027-0cdcbb5c815a2023-12-17Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutions07da67b1-b50c-4471-8cde-8a119eb8c9352023-12-15Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMProficient Rx LPbefcc5b0-04bb-4211-b3dd-88f400c7fa782023-08-01Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutionsd8239804-d234-491b-965d-89a7796a5e4d2023-02-04Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMDenton Pharma, Inc. DBA Northwind Pharmaceuticalsa12bf393-d8ef-48df-e053-2a95a90a1af12023-01-01Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMProficient Rx LPc407381f-3d8e-4fdf-9132-cd39680992962022-10-01Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMProficient Rx LP29e83667-8d4a-49b7-9182-653cbfb2dee72022-05-02Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMAsclemed USA, Inc.e6c0f80a-ba22-4690-aaf8-48a4602b68312020-09-04Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMVista Pharmaceuticals, Inc.3edca473-8fdc-462a-b378-6c3279503a702020-01-22Warnings, Adverse reactionsName fallback
brand name: Sulfamethoxazole and Trimethoprim
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMProficient Rx LP0df74ba1-1aa6-467c-92e7-6b017c7c6bce2019-11-01Warnings, 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 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
12634-779SULFAMETHOXAZOLE and TRIMETHOPRIMSULFAMETHOXAZOLE and TRIMETHOPRIMApotheca, Inc.ANDACurrent
17856-0823Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimAtlantic Biologicals CorpsANDACurrent
17856-0823Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimAtlantic Biologicals CorpsANDACurrent
21695-701Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimRebel Distributors CorpANDACurrent
50090-4584Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimA-S Medication SolutionsANDACurrent
50383-823Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-823Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-823Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimAkorn Operating Company LLCANDACurrent
50383-823Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-824Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-824Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-824Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimAkorn Operating Company LLCANDACurrent
50383-824Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimHi-Tech Pharmacal Co., Inc.ANDACurrent
52959-766Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimH.J. Harkins Company, Inc.ANDACurrent
68788-9102Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimPreferred PharmaceuticalsANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18360SUPPL2014-02-06
42857ORIG2012-04-13