Application 071017

Type
ANDA
Sponsor
SUN PHARM INDUSTRIES

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 1.

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
A071017-001SULFAMETHOXAZOLE AND TRIMETHOPRIMSULFAMETHOXAZOLE; TRIMETHOPRIM800MG;160MGTABLET / ORALAB1986-08-25
A071017-002SULFAMETHOXAZOLE AND TRIMETHOPRIMSULFAMETHOXAZOLE; TRIMETHOPRIM400MG;80MGTABLET / ORALAB1986-08-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A071017-001AB
A071017-002AB

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A071017-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB1986-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071017-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB1986-08-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071017-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB1986-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071017-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB1986-08-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A071017-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB1986-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071017-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB1986-08-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071017-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB1986-08-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071017-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB1986-08-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071017-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB1986-08-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071017-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB1986-08-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071017-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB1986-08-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071017-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB1986-08-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071017-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB1986-08-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071017-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB1986-08-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071017-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB1986-08-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071017-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB1986-08-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071017-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB1986-08-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071017-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB1986-08-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071017-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB1986-08-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A071017-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB1986-08-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071017-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB1986-08-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071017-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB1986-08-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071017-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB1986-08-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071017-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB1986-08-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071017-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB1986-08-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071017-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB1986-08-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071017-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB1986-08-258072bd15b7f6…
2024-05-31 18:47 UTC2024-05A071017-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB1986-08-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071017-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB1986-08-255c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071017-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB1986-08-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071017-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB1986-08-255d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A071017-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB1986-08-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071017-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB1986-08-254b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A071017-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB1986-08-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071017-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB1986-08-2574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A071017-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB1986-08-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071017-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB1986-08-25bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A071017-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB1986-08-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071017-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB1986-08-25782e0a99824c…
2021-12-28 21:50 UTC2021-12A071017-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB1986-08-25782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A071017-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071017-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071017-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071017-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071017-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071017-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071017-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071017-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071017-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071017-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071017-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071017-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071017-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071017-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071017-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071017-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071017-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071017-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071017-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A071017-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071017-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071017-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071017-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071017-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071017-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071017-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071017-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A071017-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071017-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071017-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071017-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A071017-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071017-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A071017-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071017-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A071017-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071017-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A071017-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071017-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A071017-002AB1782e0a99824c…

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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMGolden State Medical Supply, Inc.bd3161fe-23d7-458a-86a4-fb958d9c94d32025-06-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071017
application number: ANDA071017
ndc (product): 60429-259
ndc (product): 60429-258
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMSun Pharmaceutical Industries, Inc.4833319a-a7b3-4bf4-bec4-6531b43182d42025-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071017
application number: ANDA071017
ndc (product): 53489-146
ndc (product): 53489-145

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 56 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-940Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimBlenheim Pharmacal, Inc.ANDACurrent
50090-1541Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimA-S Medication SolutionsANDACurrent
50090-1541Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimA-S Medication SolutionsANDACurrent
50090-1541Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimA-S Medication SolutionsANDACurrent
50090-1542Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimA-S Medication SolutionsANDACurrent
50090-1542Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimA-S Medication SolutionsANDACurrent
50090-1542Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimA-S Medication SolutionsANDACurrent
50090-1543Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimA-S Medication SolutionsANDACurrent
50090-1543Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimA-S Medication SolutionsANDACurrent
50090-1543Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimA-S Medication SolutionsANDACurrent
50090-1545Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimA-S Medication SolutionsANDACurrent
50090-1545Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimA-S Medication SolutionsANDACurrent
50090-2873Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimA-S Medication SolutionsANDACurrent
50090-2890Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimA-S Medication SolutionsANDACurrent
51655-187Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimNorthwind PharmaceuticalsANDACurrent
53489-145Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimSun Pharmaceutical Industries, Inc.ANDACurrent
53489-145Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimSun Pharmaceutical Industries, Inc.ANDACurrent
53489-145Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimSun Pharmaceutical Industries, Inc.ANDACurrent
53489-145Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimSun Pharmaceutical Industries, Inc.ANDACurrent
53489-145Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimSun Pharmaceutical Industries, Inc.ANDACurrent
53489-146Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimSun Pharmaceutical Industries, Inc.ANDACurrent
53489-146Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimSun Pharmaceutical Industries, Inc.ANDACurrent
53489-146Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimSun Pharmaceutical Industries, Inc.ANDACurrent
53489-146Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimSun Pharmaceutical Industries, Inc.ANDACurrent
53489-146Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimSun Pharmaceutical Industries, Inc.ANDACurrent
53808-0914Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMState of Florida DOH Central PharmacyANDACurrent
55154-4390Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimCardinal HealthANDACurrent
60429-258Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimGolden State Medical Supply, Inc.ANDACurrent
60429-258Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimGolden State Medical Supply, Inc.ANDACurrent
60429-258Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimGolden State Medical Supply, Inc.ANDACurrent
60429-258Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimGolden State Medical Supply, Inc.ANDACurrent
60429-258Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimGolden State Medical Supply, Inc.ANDACurrent
60429-258Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimGolden State Medical Supply, Inc.ANDACurrent
60429-258Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimGolden State Medical Supply, Inc.ANDACurrent
60429-259Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimGolden State Medical Supply, Inc.ANDACurrent
60429-259Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimGolden State Medical Supply, Inc.ANDACurrent
60429-259Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimGolden State Medical Supply, Inc.ANDACurrent
60429-259Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimGolden State Medical Supply, Inc.ANDACurrent
60429-259Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimGolden State Medical Supply, Inc.ANDACurrent
60429-259Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimGolden State Medical Supply, Inc.ANDACurrent
60429-259Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimGolden State Medical Supply, Inc.ANDACurrent
61919-210SULFAMETHOXAZOLE AND TRIMETHOPRIMSULFAMETHOXAZOLE AND TRIMETHOPRIMDIRECT RXANDACurrent
63629-6357Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimBryant Ranch PrepackANDACurrent
63629-6357Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimBryant Ranch PrepackANDACurrent
63629-6799Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimBryant Ranch PrepackANDACurrent
63629-6799Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimBryant Ranch PrepackANDACurrent
63739-228Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimMcKesson Corporation dba SKY PackagingANDACurrent
63739-228Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimMcKesson CorporationANDACurrent
64725-0146Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimTYA PharmaceuticalsANDACurrent
67296-0387Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimRedPharm Drug, Inc.ANDACurrent
67296-0387Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimRedPharm Drug, Inc.ANDACurrent
67296-0387Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimRedPharm Drug, Inc.ANDACurrent
70934-043Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-043Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
76413-135Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimCentral Texas Community Health CentersANDACurrent
76413-151Sulfamethoxazole and TrimethoprimSulfamethoxazole and TrimethoprimCentral Texas Community Health CentersANDACurrent