OGSIVEO
These highlights do not include all the information needed to use OGSIVEO safely and effectively. See full prescribing information for OGSIVEO. OGSIVEO (nirogacestat) tablets, for oral use Initial U.S. Approval: 2023
Approved
Approval ID
f172e6ff-3190-41b0-b95a-58a7ef9e9e1e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 20, 2023
Manufacturers
FDA
SpringWorks Therapeutics, Inc.
DUNS: 116976800
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
nirogacestat
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82448-050
Application NumberNDA217677
Product Classification
M
Marketing Category
C73594
G
Generic Name
nirogacestat
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2023
FDA Product Classification
INGREDIENTS (11)
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
GLYCERYL MONOCAPRYLOCAPRATEInactive
Code: G7515SW10N
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
NIROGACESTATActive
Quantity: 50 mg in 1 1
Code: QZ62892OFJ
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT