FDA.reportPublic FDA data

Application 077696

Type
ANDA
Sponsor
CHARTWELL MOLECULAR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATETABLET; ORAL25MGNoNo
002SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATETABLET; ORAL50MGNoNo
003SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATETABLET; ORAL100MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 2 of 3 · 47 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEDirect_Rxf6c95873-576d-a1c2-e053-6294a90a3ff92025-01-22Warnings, Adverse reactionsName fallback
brand name: Sumatriptan Succinate
generic name: SUMATRIPTAN SUCCINATE
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEDirect_Rxf6c907a3-9624-f893-e053-6294a90a31af2025-01-22Warnings, Adverse reactionsName fallback
brand name: Sumatriptan Succinate
generic name: SUMATRIPTAN SUCCINATE
Sumatriptan SuccinateSUMATRIPTAN SUCCINATENuCare Pharmaceuticals,Inc.7628caf4-5272-4e42-e053-2a91aa0a2f242025-01-08Warnings, Adverse reactionsName fallback
brand name: Sumatriptan Succinate
generic name: SUMATRIPTAN SUCCINATE
SumatriptanSUMATRIPTAN SUCCINATENuCare Pharmaceuticals, Inc.2a96f37d-03f6-678c-e063-6394a90ae0c62024-12-31Warnings, Adverse reactionsName fallback
generic name: SUMATRIPTAN SUCCINATE
SumatriptanSUMATRIPTAN SUCCINATEQuality Care Products, LLC5d1f3de0-684a-4092-be30-aa325ff20d042024-12-18Warnings, Adverse reactionsName fallback
generic name: SUMATRIPTAN SUCCINATE
SumatriptanSUMATRIPTAN SUCCINATEQuality Care Products, LLCda77dfc4-551c-4e0e-a65e-cb478f193cd92024-12-18Warnings, Adverse reactionsName fallback
generic name: SUMATRIPTAN SUCCINATE
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEDirect_Rx284ee7ac-759e-b592-e063-6394a90a78ba2024-12-02Warnings, Adverse reactionsName fallback
brand name: Sumatriptan Succinate
generic name: SUMATRIPTAN SUCCINATE
Sumatriptan SuccinateSUMATRIPTAN SUCCINATENuCare Pharmaceuticals,Inc.b297a466-7d24-9ebd-e053-2a95a90af4d12024-07-17Warnings, Adverse reactionsName fallback
brand name: Sumatriptan Succinate
generic name: SUMATRIPTAN SUCCINATE
SumatriptanSUMATRIPTAN SUCCINATENuCare Pharmaceuticals,Inc.54c6f8f4-5466-3988-e054-00144ff8d46c2024-07-10Warnings, Adverse reactionsName fallback
generic name: SUMATRIPTAN SUCCINATE
SumatriptanSUMATRIPTAN SUCCINATENuCare Pharmaceuticals,Inc.933f6575-a4c4-0f65-e053-2a95a90ab9672024-06-19Name fallback
generic name: SUMATRIPTAN SUCCINATE
SumatriptanSUMATRIPTAN SUCCINATENuCare Pharmaceuticals,Inc.85295be9-852d-4e21-e053-2991aa0a8a782024-06-14Warnings, Adverse reactionsName fallback
generic name: SUMATRIPTAN SUCCINATE
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEFresenius Kabi USA, LLCb183c7ba-2cc6-4854-a9a6-71ccd35925862024-04-12Warnings, Adverse reactionsName fallback
brand name: Sumatriptan Succinate
generic name: SUMATRIPTAN SUCCINATE
sumatriptan succinateSUMATRIPTAN SUCCINATEA-S Medication Solutions97016a59-3b49-4134-85aa-8c866f2856012023-11-22Warnings, Adverse reactionsName fallback
brand name: sumatriptan succinate
generic name: SUMATRIPTAN SUCCINATE
Sumatriptan SuccinateSUMATRIPTAN SUCCINATENorthStar Rx LLC38fd19bf-b7aa-812c-8a74-2414dfec45f42023-03-01Warnings, Adverse reactionsName fallback
brand name: Sumatriptan Succinate
generic name: SUMATRIPTAN SUCCINATE
SumatriptanSUMATRIPTAN SUCCINATEProficient Rx LPfe09fab6-b9e3-469c-9a38-bcc343dcc8992023-01-01Warnings, Adverse reactionsName fallback
generic name: SUMATRIPTAN SUCCINATE
SumatriptanSUMATRIPTAN SUCCINATEAsclemed USA, Inc.77f9f135-e840-48f0-81e8-73e08433e7682022-10-11Warnings, Adverse reactionsName fallback
generic name: SUMATRIPTAN SUCCINATE
SumatriptanSUMATRIPTAN SUCCINATEProficient Rx LPabbd2168-1523-4eb6-a75c-dc4d7d1b1c9b2022-06-01Warnings, Adverse reactionsName fallback
generic name: SUMATRIPTAN SUCCINATE
SumatriptanSUMATRIPTAN SUCCINATEProficient Rx LP1042b91c-715c-4e90-b9cc-d91a17f9f7cb2022-04-01Warnings, Adverse reactionsName fallback
generic name: SUMATRIPTAN SUCCINATE
sumatriptan succinateSUMATRIPTAN SUCCINATEProficient Rx LP9f4d487a-c5f7-4707-976b-64e738c98d452022-04-01Warnings, Adverse reactionsName fallback
brand name: sumatriptan succinate
generic name: SUMATRIPTAN SUCCINATE
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEDr. Reddy's Laboratories Limited4e26764d-ce26-e5ac-e6db-0f1f7a1d5c2b2021-12-21Warnings, Adverse reactionsName fallback
brand name: Sumatriptan Succinate
generic name: SUMATRIPTAN SUCCINATE