Evoxac
EVOXAC Capsules(cevimeline hydrochloride)
Approved
Approval ID
0679dd4c-fece-4c6d-b273-2c62237e8973
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 3, 2022
Manufacturers
FDA
Daiichi Sankyo, Inc.
DUNS: 844277256
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
cevimeline hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63395-201
Application NumberNDA020989
Product Classification
M
Marketing Category
C73594
G
Generic Name
cevimeline hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 3, 2022
FDA Product Classification
INGREDIENTS (4)
CEVIMELINE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: P81Q6V85NP
Classification: ACTIR
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT