Application 219036

Type
ANDA
Sponsor
VKT PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATETABLET;ORALEQ 25MG BASENoNo
002SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATETABLET;ORALEQ 50MG BASENoNo
003SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATETABLET;ORALEQ 100MG BASENoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219036-001SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2024-12-31
A219036-002SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2024-12-31
A219036-003SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2024-12-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A219036-001AB
A219036-002AB
A219036-003AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A219036-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2024-12-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219036-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2024-12-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219036-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2024-12-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219036-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2024-12-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219036-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2024-12-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219036-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2024-12-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A219036-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2024-12-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A219036-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2024-12-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A219036-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2024-12-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A219036-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2024-12-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A219036-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2024-12-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A219036-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2024-12-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A219036-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2024-12-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A219036-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2024-12-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A219036-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2024-12-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A219036-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2024-12-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A219036-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2024-12-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A219036-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2024-12-3103ed91905a0d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219036-001SUMATRIPTAN SUCCINATEEQ 25MG BASETABLET / ORALAB2024-12-31a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219036-002SUMATRIPTAN SUCCINATEEQ 50MG BASETABLET / ORALAB2024-12-31a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219036-003SUMATRIPTAN SUCCINATEEQ 100MG BASETABLET / ORALAB2024-12-31a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A219036-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219036-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219036-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219036-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219036-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219036-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A219036-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A219036-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A219036-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A219036-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A219036-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A219036-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A219036-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A219036-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A219036-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A219036-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A219036-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A219036-003AB103ed91905a0d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219036-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219036-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219036-003AB1a50c72e98297…

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
sumatriptanSUMATRIPTANRising Pharma Holdings, Inc.352d2ab3-d2c7-48c8-bcd4-d46ed9bdfa852025-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219036
application number: ANDA219036