Enablex
ENABLEX (darifenacin) Extended -release tablets Rx only Prescribing Information
Approved
Approval ID
a293cece-e97a-4e67-be72-b187568e3b11
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 1, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
darifenacin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5363
Application NumberNDA021513
Product Classification
M
Marketing Category
C73594
G
Generic Name
darifenacin
Product Specifications
Route of AdministrationORAL
Effective DateJuly 29, 2010
FDA Product Classification
INGREDIENTS (9)
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
DARIFENACINActive
Quantity: 15 mg in 1 1
Code: APG9819VLM
Classification: ACTIB
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
darifenacin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5704
Application NumberNDA021513
Product Classification
M
Marketing Category
C73594
G
Generic Name
darifenacin
Product Specifications
Route of AdministrationORAL
Effective DateJuly 29, 2010
FDA Product Classification
INGREDIENTS (7)
DARIFENACINActive
Quantity: 7.5 mg in 1 1
Code: APG9819VLM
Classification: ACTIB
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT