FDA.reportPublic FDA data

Application 078318

Type
ANDA
Sponsor
TEVA PARENTERAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATEINJECTABLE;SUBCUTANEOUSEQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)NoNo
002SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATEINJECTABLE;SUBCUTANEOUSEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)NoNo

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
A078318-001SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATEEQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)INJECTABLE / SUBCUTANEOUS2009-02-06
A078318-002SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2009-02-06

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
2026-08-01 22:54:322026-06A078318-001SUMATRIPTAN SUCCINATEEQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)INJECTABLE / SUBCUTANEOUS2009-02-06a50c72e98297…
2026-08-01 22:54:322026-06A078318-002SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2009-02-06a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 3 · 47 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sumatriptan SuccinateSUMATRIPTAN SUCCINATESportpharm LLC7d3602a1-1cd5-41c2-a0a3-3d20e90a92fa2026-07-09Warnings, Adverse reactionsName fallback
brand name: Sumatriptan Succinate
generic name: SUMATRIPTAN SUCCINATE
sumatriptan succinateSUMATRIPTAN SUCCINATESun Pharmaceutical Industries, Inc.9485cc30-15e8-4b53-876d-db317145474b2026-06-25Warnings, Adverse reactionsName fallback
brand name: sumatriptan succinate
generic name: SUMATRIPTAN SUCCINATE
SumatriptanSUMATRIPTAN SUCCINATEREMEDYREPACK INC.73c9ac06-b55e-41e0-90ec-deb250f37eb52026-05-19Warnings, Adverse reactionsName fallback
generic name: SUMATRIPTAN SUCCINATE
SumatriptanSUMATRIPTAN SUCCINATEAurobindo Pharma Limitedb2503fff-c978-4efa-b1b4-d7740b6b26f22026-05-12Warnings, Adverse reactionsName fallback
generic name: SUMATRIPTAN SUCCINATE
SumatriptanSUMATRIPTAN SUCCINATESportpharm LLCd071aef6-a5bd-4f68-ba6d-03004466897c2026-04-24Warnings, Adverse reactionsName fallback
generic name: SUMATRIPTAN SUCCINATE
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEGolden State Medical Supply, Inc.1bf70380-8272-4c0d-8841-d39ef27723512026-04-15Warnings, Adverse reactionsName fallback
brand name: Sumatriptan Succinate
generic name: SUMATRIPTAN SUCCINATE
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEDr. Reddy's Laboratories Limitedac80d018-6abf-2e41-ddea-90b4ff9e90132026-03-21Warnings, Adverse reactionsName fallback
brand name: Sumatriptan Succinate
generic name: SUMATRIPTAN SUCCINATE
SumatriptanSUMATRIPTAN SUCCINATEA-S Medication Solutions62ba6fef-467a-4500-993c-51907f12a67c2026-02-14Warnings, Adverse reactionsName fallback
generic name: SUMATRIPTAN SUCCINATE
SumatriptanSUMATRIPTAN SUCCINATENorthStar Rx LLC84bfc4ba-4172-4adb-b963-4e0eb438c07a2026-02-13Warnings, Adverse reactionsName fallback
generic name: SUMATRIPTAN SUCCINATE
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEDr. Reddys Laboratories Inc.,8fef1176-7a38-eca3-22ca-83efe5ca66202026-01-21Warnings, Adverse reactionsName fallback
brand name: Sumatriptan Succinate
generic name: SUMATRIPTAN SUCCINATE
ZEMBRACE SYMTOUCHSUMATRIPTAN SUCCINATEUpsher-Smith laboratories, LLC6e5b104f-2b9e-416e-92fb-ef1bdaea867d2026-01-09Warnings, Adverse reactionsName fallback
generic name: SUMATRIPTAN SUCCINATE
Sumatriptan SuccinateSUMATRIPTAN SUCCINATESun Pharmaceutical Industries, Inc.f235152e-dd8d-4679-9d9f-404fe5ff4fba2026-01-08Warnings, Adverse reactionsName fallback
brand name: Sumatriptan Succinate
generic name: SUMATRIPTAN SUCCINATE
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEMylan Pharmaceuticals Inc.1d2cd01c-05e7-44cf-a71d-0f474e826b7e2026-01-01Warnings, Adverse reactionsName fallback
brand name: Sumatriptan Succinate
generic name: SUMATRIPTAN SUCCINATE
SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATEAlembic Pharmaceuticals Limited16b7e44d-afa0-4177-80ef-c3ae9a78a4e12025-11-17Warnings, Adverse reactionsName fallback
brand name: SUMATRIPTAN SUCCINATE
generic name: SUMATRIPTAN SUCCINATE
SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATEAlembic Pharmaceuticals Inc.0e8b65f7-9d3b-42f2-8d7e-69b1433659802025-11-14Warnings, Adverse reactionsName fallback
brand name: SUMATRIPTAN SUCCINATE
generic name: SUMATRIPTAN SUCCINATE
SumatriptanSUMATRIPTAN SUCCINATEPreferred Pharmaceuticals, Inc.f2e7d756-1e12-462a-a43f-a9d860b11ee82025-09-25Warnings, Adverse reactionsName fallback
generic name: SUMATRIPTAN SUCCINATE
SumatriptanSUMATRIPTAN SUCCINATEPreferred Pharmaceuticals, Inc.bf9fd9fe-095b-4478-bd2e-a5534af077612025-09-25Warnings, Adverse reactionsName fallback
generic name: SUMATRIPTAN SUCCINATE
SumatriptanSUMATRIPTAN SUCCINATEPreferred Pharmaceuticals Inc.baf37e8c-d414-4ca7-a366-97dc202372ff2025-09-25Warnings, Adverse reactionsName fallback
generic name: SUMATRIPTAN SUCCINATE
Zembrace SymTouchSUMATRIPTAN SUCCINATETonix Medicines, Inc.3eb49807-fa9d-4a0d-9a3c-76de5b23b01b2025-02-28Warnings, Adverse reactionsName fallback
generic name: SUMATRIPTAN SUCCINATE
SumatriptanSUMATRIPTAN SUCCINATENuCare Pharmaceuticals, Inc.2efd4269-5657-9669-e063-6394a90a583a2025-02-25Warnings, Adverse reactionsName fallback
generic name: SUMATRIPTAN SUCCINATE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39556ORIG2009-02-06