CEVIMELINE HYDROCHLORIDE
Cevimeline hydrochloride Capsules 30mg
Approved
Approval ID
61dd5ee1-cf89-43ea-ada4-4e4a4d9d133b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 3, 2023
Manufacturers
FDA
Advagen Pharma Ltd
DUNS: 051627256
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 Code72888-118
Application NumberANDA216682
Product Classification
M
Marketing Category
C73584
G
Generic Name
CEVIMELINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateMay 3, 2023
FDA Product Classification
INGREDIENTS (11)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
CEVIMELINE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: P81Q6V85NP
Classification: ACTIR