Desvenlafaxine
These highlights do not include all the information needed to use DESVENLAFAXINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DESVENLAFAXINE EXTENDED-RELEASE TABLETS. DESVENLAFAXINE extended-release tablets, for oral useInitial U.S. Approval: 2008
Approved
Approval ID
c05fd27e-21a1-4497-8287-b09ea82433c2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 6, 2018
Manufacturers
FDA
Carilion Materials Management
DUNS: 079239644
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
desvenlafaxine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68151-5295
Application NumberANDA204095
Product Classification
M
Marketing Category
C73584
G
Generic Name
desvenlafaxine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 2, 2017
FDA Product Classification
INGREDIENTS (11)
DESVENLAFAXINE SUCCINATEActive
Quantity: 50 mg in 1 1
Code: ZB22ENF0XR
Classification: ACTIM
HYDROXYPROPYL CELLULOSE (1200000 MW)Inactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT