FDA.reportPublic FDA data

Application 206336

Type
ANDA
Sponsor
PAR PHARM INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BALSALAZIDE DISODIUMBALSALAZIDE DISODIUMTABLET;ORAL1.1GMNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A206336-001BALSALAZIDE DISODIUMBALSALAZIDE DISODIUM1.1GMTABLET / ORAL2015-09-08

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A206336-001BALSALAZIDE DISODIUM1.1GMTABLET / ORAL2015-09-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206336-001BALSALAZIDE DISODIUM1.1GMTABLET / ORAL2015-09-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A206336-001BALSALAZIDE DISODIUM1.1GMTABLET / ORAL2015-09-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206336-001BALSALAZIDE DISODIUM1.1GMTABLET / ORAL2015-09-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206336-001BALSALAZIDE DISODIUM1.1GMTABLET / ORAL2015-09-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206336-001BALSALAZIDE DISODIUM1.1GMTABLET / ORAL2015-09-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206336-001BALSALAZIDE DISODIUM1.1GMTABLET / ORAL2015-09-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206336-001BALSALAZIDE DISODIUM1.1GMTABLET / ORAL2015-09-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206336-001BALSALAZIDE DISODIUM1.1GMTABLET / ORAL2015-09-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206336-001BALSALAZIDE DISODIUM1.1GMTABLET / ORAL2015-09-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206336-001BALSALAZIDE DISODIUM1.1GMTABLET / ORAL2015-09-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206336-001BALSALAZIDE DISODIUM1.1GMTABLET / ORAL2015-09-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206336-001BALSALAZIDE DISODIUM1.1GMTABLET / ORAL2015-09-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206336-001BALSALAZIDE DISODIUM1.1GMTABLET / ORAL2015-09-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206336-001BALSALAZIDE DISODIUM1.1GMTABLET / ORAL2015-09-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206336-001BALSALAZIDE DISODIUM1.1GMTABLET / ORAL2015-09-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206336-001BALSALAZIDE DISODIUM1.1GMTABLET / ORAL2015-09-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206336-001BALSALAZIDE DISODIUM1.1GMTABLET / ORAL2015-09-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206336-001BALSALAZIDE DISODIUM1.1GMTABLET / ORAL2015-09-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206336-001BALSALAZIDE DISODIUM1.1GMTABLET / ORAL2015-09-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206336-001BALSALAZIDE DISODIUM1.1GMTABLET / ORAL2015-09-0887673890dc5c…
2021-03-12 10:30 UTC2021-03A206336-001BALSALAZIDE DISODIUM1.1GMTABLET / ORAL2015-09-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206336-001BALSALAZIDE DISODIUM1.1GMTABLET / ORAL2015-09-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206336-001BALSALAZIDE DISODIUM1.1GMTABLET / ORAL2015-09-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206336-001BALSALAZIDE DISODIUM1.1GMTABLET / ORAL2015-09-083f01610625f2…
2019-09-15 20:21 UTC2019-09A206336-001BALSALAZIDE DISODIUM1.1GMTABLET / ORAL2015-09-08b00525d2431f…
2019-07-19 19:46 UTC2019-07A206336-001BALSALAZIDE DISODIUM1.1GMTABLET / ORAL2015-09-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206336-001BALSALAZIDE DISODIUM1.1GMTABLET / ORAL2015-09-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206336-001BALSALAZIDE DISODIUM1.1GMTABLET / ORAL2015-09-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206336-001BALSALAZIDE DISODIUM1.1GMTABLET / ORAL2015-09-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206336-001BALSALAZIDE DISODIUM1.1GMTABLET / ORAL2015-09-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206336-001BALSALAZIDE DISODIUM1.1GMTABLET / ORAL2015-09-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206336-001BALSALAZIDE DISODIUM1.1GMTABLET / ORAL2015-09-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206336-001BALSALAZIDE DISODIUM1.1GMTABLET / ORAL2015-09-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A206336-001BALSALAZIDE DISODIUM1.1GMTABLET / ORAL2015-09-08053a50430f4f…
2023-01-26 05:58 UTC2023-01A206336-001BALSALAZIDE DISODIUM1.1GMTABLET / ORAL2015-09-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206336-001BALSALAZIDE DISODIUM1.1GMTABLET / ORAL2015-09-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206336-001BALSALAZIDE DISODIUM1.1GMTABLET / ORAL2015-09-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206336-001BALSALAZIDE DISODIUM1.1GMTABLET / ORAL2015-09-08e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206336-001BALSALAZIDE DISODIUM1.1GMTABLET / ORAL2015-09-08cb3db0bc1861…

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Balsalazide DisodiumBALSALAZIDE DISODIUMAvPAK509b83b6-cde6-393b-8560-557793b6a5292025-12-30Warnings, Adverse reactionsName fallback
brand name: Balsalazide Disodium
generic name: BALSALAZIDE DISODIUM
Balsalazide DisodiumBALSALAZIDE DISODIUMPD-Rx Pharmaceuticals, Inc.b3ecc533-dd55-4a2f-84c4-ecd454aae7662025-10-08Warnings, Adverse reactionsName fallback
brand name: Balsalazide Disodium
generic name: BALSALAZIDE DISODIUM
balsalazide disodiumBALSALAZIDE DISODIUMZydus Lifesciences Limitedc573888c-4aa3-4fdb-bf3f-1cf3d78d922b2025-06-13Warnings, Adverse reactionsName fallback
brand name: balsalazide disodium
generic name: BALSALAZIDE DISODIUM
balsalazide disodiumBALSALAZIDE DISODIUMZydus Pharmaceuticals (USA) Inc.0ed73067-e2ca-4184-a93a-5a2141bb48982025-06-13Warnings, Adverse reactionsName fallback
brand name: balsalazide disodium
generic name: BALSALAZIDE DISODIUM
balsalazide disodiumBALSALAZIDE DISODIUMCarnegie Pharmaceuticals, LLC620f86cb-b6a2-4af8-a642-925dd8a1c5fe2025-04-15Warnings, Adverse reactionsName fallback
brand name: balsalazide disodium
generic name: BALSALAZIDE DISODIUM
Balsalazide DisodiumBALSALAZIDE DISODIUMBryant Ranch Prepackcd73c9f1-d83b-4206-b2c6-1bd111e112632025-04-02Warnings, Adverse reactionsName fallback
brand name: Balsalazide Disodium
generic name: BALSALAZIDE DISODIUM
Balsalazide DisodiumBALSALAZIDE DISODIUMGolden State Medical Supply, Inc.029833fa-ec5c-6a39-e063-6294a90aa0632025-02-18Warnings, Adverse reactionsName fallback
brand name: Balsalazide Disodium
generic name: BALSALAZIDE DISODIUM
Balsalazide DisodiumBALSALAZIDE DISODIUMApotex Corp.f12ffa32-d14b-e9d9-e957-2ef08b64e8b42025-01-02Warnings, Adverse reactionsName fallback
brand name: Balsalazide Disodium
generic name: BALSALAZIDE DISODIUM
Balsalazide DisodiumBALSALAZIDE DISODIUMHikma Pharmaceuticals USA Inc.a0498308-14b2-4456-8e13-795f6fc8ea302024-02-22Warnings, Adverse reactionsName fallback
brand name: Balsalazide Disodium
generic name: BALSALAZIDE DISODIUM

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32800ORIG2015-09-10