cevimeline hydrochloride
Cevimeline Hydrochloride
Approved
Approval ID
efc2bb24-4dda-4781-bef5-fcd9abf082dd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 5, 2023
Manufacturers
FDA
Cosette Pharmaceuticals, Inc.
DUNS: 116918230
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 Code0713-0937
Application NumberNDA020989
Product Classification
M
Marketing Category
C73594
G
Generic Name
cevimeline hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 5, 2023
FDA Product Classification
INGREDIENTS (4)
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CEVIMELINE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: P81Q6V85NP
Classification: ACTIR