VOWST
These highlights do not include all the information needed to use VOWST™ safely and effectively. See full prescribing information for VOWST. VOWST (fecal microbiota spores, live-brpk) capsules, for oral administration Initial U.S. Approval: 2023
Approved
Approval ID
99e5a37a-930c-4641-bcdd-7013ec1c15fe
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 21, 2023
Manufacturers
FDA
Aimmune Therapeutics, Inc.
DUNS: 057562771
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
fecal microbiota spores, live-brpk
PRODUCT DETAILS
NDC Product Code71881-400
Application NumberBLA125757
Marketing CategoryC73585
Route of AdministrationORAL
Effective DateApril 21, 2023
Generic Namefecal microbiota spores, live-brpk
INGREDIENTS (4)
DONOR HUMAN STOOL SPORES (ETHANOL TREATED)Active
Quantity: 30000000 [CFU] in 1 1
Code: 9K7X6R5BMW
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT