FDA.reportPublic FDA data

Application 086750

Type
ANDA
Sponsor
ORGANON USA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001WIGRETTESERGOTAMINE TARTRATETABLET;SUBLINGUAL2MGNoNo

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
A086750-001WIGRETTESERGOTAMINE TARTRATE2MGTABLET / SUBLINGUAL1982-07-29

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 UTC2026-02A086750-001WIGRETTES2MGTABLET / SUBLINGUAL1982-07-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A086750-001WIGRETTES2MGTABLET / SUBLINGUAL1982-07-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A086750-001WIGRETTES2MGTABLET / SUBLINGUAL1982-07-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A086750-001WIGRETTES2MGTABLET / SUBLINGUAL1982-07-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A086750-001WIGRETTES2MGTABLET / SUBLINGUAL1982-07-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A086750-001WIGRETTES2MGTABLET / SUBLINGUAL1982-07-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A086750-001WIGRETTES2MGTABLET / SUBLINGUAL1982-07-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A086750-001WIGRETTES2MGTABLET / SUBLINGUAL1982-07-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A086750-001WIGRETTES2MGTABLET / SUBLINGUAL1982-07-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A086750-001WIGRETTES2MGTABLET / SUBLINGUAL1982-07-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A086750-001WIGRETTES2MGTABLET / SUBLINGUAL1982-07-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A086750-001WIGRETTES2MGTABLET / SUBLINGUAL1982-07-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A086750-001WIGRETTES2MGTABLET / SUBLINGUAL1982-07-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A086750-001WIGRETTES2MGTABLET / SUBLINGUAL1982-07-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A086750-001WIGRETTES2MGTABLET / SUBLINGUAL1982-07-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A086750-001WIGRETTES2MGTABLET / SUBLINGUAL1982-07-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A086750-001WIGRETTES2MGTABLET / SUBLINGUAL1982-07-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A086750-001WIGRETTES2MGTABLET / SUBLINGUAL1982-07-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A086750-001WIGRETTES2MGTABLET / SUBLINGUAL1982-07-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A086750-001WIGRETTES2MGTABLET / SUBLINGUAL1982-07-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A086750-001WIGRETTES2MGTABLET / SUBLINGUAL1982-07-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A086750-001WIGRETTES2MGTABLET / SUBLINGUAL1982-07-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A086750-001WIGRETTES2MGTABLET / SUBLINGUAL1982-07-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A086750-001WIGRETTES2MGTABLET / SUBLINGUAL1982-07-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A086750-001WIGRETTES2MGTABLET / SUBLINGUAL1982-07-293f01610625f2…
2019-09-15 20:21 UTC2019-09A086750-001WIGRETTES2MGTABLET / SUBLINGUAL1982-07-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A086750-001WIGRETTES2MGTABLET / SUBLINGUAL1982-07-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A086750-001WIGRETTES2MGTABLET / SUBLINGUAL1982-07-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A086750-001WIGRETTES2MGTABLET / SUBLINGUAL1982-07-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A086750-001WIGRETTES2MGTABLET / SUBLINGUAL1982-07-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A086750-001WIGRETTES2MGTABLET / SUBLINGUAL1982-07-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A086750-001WIGRETTES2MGTABLET / SUBLINGUAL1982-07-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A086750-001WIGRETTES2MGTABLET / SUBLINGUAL1982-07-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A086750-001WIGRETTES2MGTABLET / SUBLINGUAL1982-07-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A086750-001WIGRETTES2MGTABLET / SUBLINGUAL1982-07-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A086750-001WIGRETTES2MGTABLET / SUBLINGUAL1982-07-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A086750-001WIGRETTES2MGTABLET / SUBLINGUAL1982-07-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A086750-001WIGRETTES2MGTABLET / SUBLINGUAL1982-07-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A086750-001WIGRETTES2MGTABLET / SUBLINGUAL1982-07-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A086750-001WIGRETTES2MGTABLET / SUBLINGUAL1982-07-29cb3db0bc1861…

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
Ergomar SublingualERGOTAMINE TARTRATEPangea Pharmaceuticals LLCa9582fdb-7ddd-4f69-aa7a-66247cdb8c922025-02-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ERGOTAMINE TARTRATE