Cevimeline Hydrochloride
CEVIMELINE HYDROCHLORIDE CAPSULES
Approved
Approval ID
51307f82-66f2-41c7-80ff-174d7e50f7ee
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 27, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
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
NDC Product Code63629-9863
Application NumberANDA203775
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 3, 2018
Generic NameCevimeline Hydrochloride
INGREDIENTS (4)
CEVIMELINE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: P81Q6V85NP
Classification: ACTIR
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT