FDA.reportPublic FDA data

Application 085828

Type
ANDA
Sponsor
WATSON LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SULFASALAZINESULFASALAZINETABLET;ORAL500MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A085828-001SULFASALAZINESULFASALAZINE500MGTABLET / ORALABApproved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A085828-001AB

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A085828-001SULFASALAZINE500MGTABLET / ORALABApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A085828-001SULFASALAZINE500MGTABLET / ORALABApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A085828-001SULFASALAZINE500MGTABLET / ORALABApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A085828-001SULFASALAZINE500MGTABLET / ORALABApproved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A085828-001AB1c2088c7a36db…
2026-09-14 22:38:342026-08A085828-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A085828-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A085828-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085828-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A085828-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085828-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085828-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085828-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085828-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085828-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085828-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A085828-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085828-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085828-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085828-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A085828-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A085828-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A085828-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A085828-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A085828-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A085828-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A085828-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A085828-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A085828-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A085828-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A085828-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A085828-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A085828-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A085828-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A085828-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A085828-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A085828-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A085828-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A085828-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A085828-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A085828-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A085828-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A085828-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A085828-001AB13a93d1ddd44b…

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
SulfasalazineSULFASALAZINEBryant Ranch Prepack618c5324-d0a6-4d00-9b12-0de88a71c1802024-04-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085828
application number: ANDA085828
SulfasalazineSULFASALAZINETeva Pharmaceuticals USA, Inc.3c59593b-e1a5-47cb-a82b-3e5e492053442023-08-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085828
application number: ANDA085828
ndc (product): 0093-3234

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 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-3234SulfasalazineSulfasalazineTeva Pharmaceuticals USA, Inc.ANDACurrent
0591-0796SulfasalazineSulfasalazineActavis Pharma, Inc.ANDACurrent
0591-0796SulfasalazineSulfasalazineActavis Pharma, Inc.ANDACurrent
0591-0796SulfasalazineSulfasalazineActavis Pharma, Inc.ANDACurrent
0591-0796SulfasalazineSulfasalazineActavis Pharma, Inc.ANDACurrent
0591-0796SulfasalazineSulfasalazineActavis Pharma, Inc.ANDACurrent
50090-2013SulfasalazineSulfasalazineA-S Medication SolutionsANDACurrent
50090-2013SulfasalazineSulfasalazineA-S Medication SolutionsANDACurrent
50090-2013SulfasalazineSulfasalazineA-S Medication SolutionsANDACurrent
50268-730SulfasalazineSulfasalazineAvPAKANDACurrent
50268-730SulfasalazineSulfasalazineAvPAKANDACurrent
63629-5688SulfasalazineSulfasalazineBryant Ranch PrepackANDACurrent
63629-5688SulfasalazineSulfasalazineBryant Ranch PrepackANDACurrent
63629-5688SulfasalazineSulfasalazineBryant Ranch PrepackANDACurrent
63629-5688SulfasalazineSulfasalazineBryant Ranch PrepackANDACurrent
68071-4215SulfasalazineSulfasalazineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4215SulfasalazineSulfasalazineNuCare Pharmaceuticals,Inc.ANDACurrent
70518-0185SulfasalazineSulfasalazineREMEDYREPACK INC.ANDACurrent
70518-0185SulfasalazineSulfasalazineREMEDYREPACK INC.ANDACurrent
70518-0185SulfasalazineSulfasalazineREMEDYREPACK INC.ANDACurrent
70518-0185SulfasalazineSulfasalazineREMEDYREPACK INC.ANDACurrent
70518-0185SulfasalazineSulfasalazineREMEDYREPACK INC.ANDACurrent
70518-0185SulfasalazineSulfasalazineREMEDYREPACK INC.ANDACurrent
70518-0185SulfasalazineSulfasalazineREMEDYREPACK INC.ANDACurrent
70518-2342SulfasalazineSulfasalazineREMEDYREPACK INC.ANDACurrent
70518-2342SulfasalazineSulfasalazineREMEDYREPACK INC.ANDACurrent
70518-2342SulfasalazineSulfasalazineREMEDYREPACK INC.ANDACurrent
70518-2342SulfasalazineSulfasalazineREMEDYREPACK INC.ANDACurrent
70518-2342SulfasalazineSulfasalazineREMEDYREPACK INC.ANDACurrent
71610-577SulfasalazineSulfasalazineAphena Pharma Solutions - Tennessee, LLCANDACurrent