Application 022377

Type
NDA
Sponsor
MERIDIAN MEDCL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALSUMASUMATRIPTAN 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022377-001ALSUMASUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2010-06-29

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022377-00178112542027-08-26U-1083Drug product2010-10-13

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 UTC2026-02N022377-001ALSUMAEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2010-06-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022377-001ALSUMAEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2010-06-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N022377-001ALSUMAEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2010-06-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022377-001ALSUMAEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2010-06-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022377-001ALSUMAEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2010-06-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022377-001ALSUMAEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2010-06-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022377-001ALSUMAEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2010-06-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022377-001ALSUMAEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2010-06-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022377-001ALSUMAEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2010-06-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022377-001ALSUMAEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2010-06-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022377-001ALSUMAEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2010-06-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022377-001ALSUMAEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2010-06-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022377-001ALSUMAEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2010-06-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022377-001ALSUMAEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2010-06-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022377-001ALSUMAEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2010-06-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022377-001ALSUMAEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2010-06-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022377-001ALSUMAEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2010-06-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022377-001ALSUMAEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2010-06-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022377-001ALSUMAEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2010-06-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022377-001ALSUMAEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2010-06-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022377-001ALSUMAEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2010-06-2987673890dc5c…
2021-03-12 10:30 UTC2021-03N022377-001ALSUMAEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2010-06-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022377-001ALSUMAEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2010-06-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022377-001ALSUMAEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2010-06-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022377-001ALSUMAEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2010-06-293f01610625f2…
2019-09-15 20:21 UTC2019-09N022377-001ALSUMAEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2010-06-29b00525d2431f…
2019-07-19 19:46 UTC2019-07N022377-001ALSUMAEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2010-06-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022377-001ALSUMAEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2010-06-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022377-001ALSUMAEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2010-06-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022377-001ALSUMAEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2010-06-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022377-001ALSUMAEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2010-06-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022377-001ALSUMAEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2010-06-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022377-001ALSUMAEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2010-06-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022377-001ALSUMAEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2010-06-293f0d92c62455…
2023-05-13 08:27 UTC2023-05N022377-001ALSUMAEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2010-06-29053a50430f4f…
2023-01-26 05:58 UTC2023-01N022377-001ALSUMAEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2010-06-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022377-001ALSUMAEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2010-06-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022377-001ALSUMAEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2010-06-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022377-001ALSUMAEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2010-06-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022377-001ALSUMAEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLE / SUBCUTANEOUS2010-06-29cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022377-00178112542027-08-26U-1083Drug product2010-10-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022377-00178112542027-08-26U-1083Drug product2010-10-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08N022377-00178112542027-08-26U-1083Drug product2010-10-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022377-00178112542027-08-26U-1083Drug product2010-10-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022377-00178112542027-08-26U-1083Drug product2010-10-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022377-00178112542027-08-26U-1083Drug product2010-10-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022377-00178112542027-08-26U-1083Drug product2010-10-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022377-00178112542027-08-26U-1083Drug product2010-10-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022377-00178112542027-08-26U-1083Drug product2010-10-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022377-00178112542027-08-26U-1083Drug product2010-10-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022377-00178112542027-08-26U-1083Drug product2010-10-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022377-00178112542027-08-26U-1083Drug product2010-10-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022377-00178112542027-08-26U-1083Drug product2010-10-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022377-00178112542027-08-26U-1083Drug product2010-10-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022377-00178112542027-08-26U-1083Drug product2010-10-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022377-00178112542027-08-26U-1083Drug product2010-10-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022377-00178112542027-08-26U-1083Drug product2010-10-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022377-00178112542027-08-26U-1083Drug product2010-10-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022377-00178112542027-08-26U-1083Drug product2010-10-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022377-00178112542027-08-26U-1083Drug product2010-10-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022377-00178112542027-08-26U-1083Drug product2010-10-1387673890dc5c…
2021-03-12 10:30 UTC2021-03N022377-00178112542027-08-26U-1083Drug product2010-10-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022377-00178112542027-08-26U-1083Drug product2010-10-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022377-00178112542027-08-26U-1083Drug product2010-10-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022377-00178112542027-08-26U-1083Drug product2010-10-133f01610625f2…
2019-09-15 20:21 UTC2019-09N022377-00178112542027-08-26U-1083Drug product2010-10-13b00525d2431f…
2019-07-19 19:46 UTC2019-07N022377-00178112542027-08-26U-1083Drug product2010-10-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022377-00178112542027-08-26U-1083Drug product2010-10-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022377-00178112542027-08-26U-1083Drug product2010-10-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022377-00178112542027-08-26U-1083Drug product2010-10-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022377-00178112542027-08-26U-1083Drug product2010-10-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022377-00178112542027-08-26U-1083Drug product2010-10-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022377-00178112542027-08-26U-1083Drug product2010-10-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022377-00178112542027-08-26U-1083Drug product2010-10-133f0d92c62455…
2023-05-13 08:27 UTC2023-05N022377-00178112542027-08-26U-1083Drug product2010-10-13053a50430f4f…
2023-01-26 05:58 UTC2023-01N022377-00178112542027-08-26U-1083Drug product2010-10-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022377-00178112542027-08-26U-1083Drug product2010-10-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022377-00178112542027-08-26U-1083Drug product2010-10-13f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022377-00178112542027-08-26U-1083Drug product2010-10-13e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022377-00178112542027-08-26U-1083Drug product2010-10-13cb3db0bc1861…

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 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
generic name: SUMATRIPTAN SUCCINATE
sumatriptan succinateSUMATRIPTAN SUCCINATESun Pharmaceutical Industries, Inc.9485cc30-15e8-4b53-876d-db317145474b2026-06-25Warnings, Adverse reactionsName fallback
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
generic name: SUMATRIPTAN SUCCINATE
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEDr. Reddy's Laboratories Limitedac80d018-6abf-2e41-ddea-90b4ff9e90132026-03-21Warnings, Adverse reactionsName fallback
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 SUCCINATEAlembic Pharmaceuticals Inc.0e8b65f7-9d3b-42f2-8d7e-69b1433659802026-01-29Warnings, Adverse reactionsName fallback
generic name: SUMATRIPTAN SUCCINATE
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEDr. Reddys Laboratories Inc.,8fef1176-7a38-eca3-22ca-83efe5ca66202026-01-21Warnings, Adverse reactionsName fallback
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
generic name: SUMATRIPTAN SUCCINATE
Sumatriptan SuccinateSUMATRIPTAN SUCCINATEMylan Pharmaceuticals Inc.1d2cd01c-05e7-44cf-a71d-0f474e826b7e2026-01-01Warnings, Adverse reactionsName fallback
generic name: SUMATRIPTAN SUCCINATE
SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATEAlembic Pharmaceuticals Limited16b7e44d-afa0-4177-80ef-c3ae9a78a4e12025-11-17Warnings, Adverse reactionsName fallback
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
38635SUPPL2014-06-10
38634SUPPL2014-06-10
29662SUPPL2014-06-10
29661SUPPL2014-06-10
24292ORIG2011-05-11
22008ORIG2011-05-11
38633ORIG2010-07-06
7305ORIG2010-07-02