FDA.reportPublic FDA data

Application 219117

Type
ANDA
Sponsor
LANNETT CO INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002SELEXIPAGSELEXIPAGTABLET1200UGNoNo
003SELEXIPAGSELEXIPAGTABLET400UGNoNo
004SELEXIPAGSELEXIPAGTABLET1000UGNoNo
005SELEXIPAGSELEXIPAGTABLET1600UGNoNo
006SELEXIPAGSELEXIPAGTABLET800UGNoNo
007SELEXIPAGSELEXIPAGTABLET600UGNoNo
008SELEXIPAGSELEXIPAGTABLET200UGNoNo

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 1 of 1 ยท 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UPTRAVISELEXIPAGActelion Pharmaceuticals US, Inc.a7a23b87-f892-4e2c-8e2e-ebf841220f902026-05-28Warnings, Adverse reactionsName fallback
generic name: SELEXIPAG
SelexipagSELEXIPAGZydus Lifesciences Limitedff660787-880f-4f2b-baac-fd2dbfcd79c22025-11-07Warnings, Adverse reactionsName fallback
brand name: Selexipag
generic name: SELEXIPAG
SelexipagSELEXIPAGZydus Pharmaceuticals (USA) Inc.c604e181-e336-4194-bf96-f65dd164d4612024-05-25Warnings, Adverse reactionsName fallback
brand name: Selexipag
generic name: SELEXIPAG