Application 203252

Type
ANDA
Sponsor
JUBILANT GENERICS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATETABLET;ORALEQ 5MG BASENoNo
002RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATETABLET;ORALEQ 10MG BASENoNo

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
A203252-001RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORAL2014-12-31
A203252-002RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORAL2014-12-31

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 UTC2026-02A203252-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORAL2014-12-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203252-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORAL2014-12-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203252-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORAL2014-12-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203252-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORAL2014-12-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203252-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORAL2014-12-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203252-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORAL2014-12-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203252-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORAL2014-12-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203252-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORAL2014-12-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203252-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORAL2014-12-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203252-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORAL2014-12-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203252-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORAL2014-12-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203252-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORAL2014-12-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203252-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORAL2014-12-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203252-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORAL2014-12-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203252-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORAL2014-12-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203252-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORAL2014-12-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203252-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORAL2014-12-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203252-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORAL2014-12-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203252-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORAL2014-12-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A203252-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORAL2014-12-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203252-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORAL2014-12-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203252-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORAL2014-12-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203252-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORAL2014-12-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203252-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORAL2014-12-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203252-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORAL2014-12-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203252-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORAL2014-12-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203252-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORAL2014-12-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203252-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORAL2014-12-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203252-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORAL2014-12-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203252-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORAL2014-12-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203252-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2014-12-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203252-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2014-12-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203252-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2014-12-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203252-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2014-12-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203252-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2014-12-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203252-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2014-12-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203252-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2014-12-31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203252-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2014-12-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203252-001RIZATRIPTAN BENZOATEEQ 5MG BASETABLET / ORALAB2014-12-31782e0a99824c…
2021-12-28 21:50 UTC2021-12A203252-002RIZATRIPTAN BENZOATEEQ 10MG BASETABLET / ORALAB2014-12-31782e0a99824c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-04-08 23:34 UTC2022-04A203252-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203252-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203252-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203252-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203252-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203252-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203252-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203252-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203252-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A203252-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203252-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203252-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A203252-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A203252-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203252-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A203252-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203252-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A203252-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203252-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A203252-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A203252-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A203252-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A203252-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A203252-002AB1ea99ee380514…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATEdirect rxb3d981bc-3c9e-8a9e-e053-2995a90a8f652026-03-05Warnings, Adverse reactionsExact identifier
ndc (product): 72189-126

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-4619rizatriptan benzoaterizatriptan benzoateA-S Medication SolutionsANDACurrent
50090-4619rizatriptan benzoaterizatriptan benzoateA-S Medication SolutionsANDACurrent
59746-414rizatriptan benzoaterizatriptan benzoateJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-414rizatriptan benzoaterizatriptan benzoateJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-415rizatriptan benzoaterizatriptan benzoateJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-415rizatriptan benzoaterizatriptan benzoateJubilant Cadista Pharmaceuticals Inc.ANDACurrent
71335-1346rizatriptan benzoaterizatriptan benzoateBryant Ranch PrepackANDACurrent
71335-1346rizatriptan benzoaterizatriptan benzoateBryant Ranch PrepackANDACurrent
72189-126RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATEdirect rxANDACurrent
72189-126RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATEdirect rxANDACurrent
72189-126RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATEdirect rxANDACurrent