VIVJOA
These highlights do not include all the information needed to use VIVJOA™ safely and effectively. See full prescribing information for VIVJOA™. VIVJOA™ (oteseconazole) capsules, for oral use Initial U.S. Approval: 2022
Approved
Approval ID
e21d5008-800e-4417-927f-14340341865f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 12, 2022
Manufacturers
FDA
Mycovia Pharmaceuticals, Inc.
DUNS: 079575708
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
oteseconazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code74695-823
Application NumberNDA215888
Product Classification
M
Marketing Category
C73594
G
Generic Name
oteseconazole
Product Specifications
Route of AdministrationORAL
Effective DateJuly 12, 2022
FDA Product Classification
INGREDIENTS (8)
MICROCRYSTALLINE CELLULOSEInactive
Quantity: 20 mg in 1 1
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
OTESECONAZOLEActive
Quantity: 150 mg in 1 1
Code: VHH774W97N
Classification: ACTIB
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT