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Darifenacin

These highlights do not include all the information needed to use DARIFENACIN EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DARIFENACIN EXTENDED-RELEASE TABLETS. DARIFENACIN extended-release tablets, for oral use Initial U.S. Approval:2004

Approved
Approval ID

e84f1ae3-b9a2-4a15-a299-c75373891cc1

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 25, 2022

Manufacturers
FDA

Torrent Pharmaceuticals Limited

DUNS: 916488547

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 Code13668-202
Application NumberANDA205209
Product Classification
M
Marketing Category
C73584
G
Generic Name
Darifenacin
Product Specifications
Route of AdministrationORAL
Effective DateApril 11, 2022
FDA Product Classification

INGREDIENTS (9)

CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
HYPROMELLOSE 2208 (4000 MPA.S)Inactive
Code: 39J80LT57T
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
DARIFENACIN HYDROBROMIDEActive
Quantity: 7.5 mg in 1 1
Code: CR02EYQ8GV
Classification: ACTIM
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

Darifenacin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code13668-203
Application NumberANDA205209
Product Classification
M
Marketing Category
C73584
G
Generic Name
Darifenacin
Product Specifications
Route of AdministrationORAL
Effective DateApril 11, 2022
FDA Product Classification

INGREDIENTS (11)

CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE 2208 (4000 MPA.S)Inactive
Code: 39J80LT57T
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
DARIFENACIN HYDROBROMIDEActive
Quantity: 15 mg in 1 1
Code: CR02EYQ8GV
Classification: ACTIM

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Darifenacin - FDA Drug Approval Details