cevimeline hydrochloride
Cevimeline Hydrochloride Capsules
Approved
Approval ID
d7432a48-1142-431e-997f-8419dc724824
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 9, 2016
Manufacturers
FDA
Novel Laboratories, Inc.
DUNS: 793518643
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 Code40032-999
Application NumberANDA204746
Product Classification
M
Marketing Category
C73584
G
Generic Name
cevimeline hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 9, 2016
FDA Product Classification
INGREDIENTS (15)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CEVIMELINE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: P81Q6V85NP
Classification: ACTIR
HYDROXYPROPYL CELLULOSE (TYPE E)Inactive
Code: 66O7AQV0RT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT