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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 use Initial U.S. Approval: 2008

Approved
Approval ID

6741bdef-dc58-47be-b28d-c43476dc8bde

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 31, 2023

Manufacturers
FDA

Bryant Ranch Prepack

DUNS: 171714327

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 Code71335-1815
Application NumberANDA210014
Product Classification
M
Marketing Category
C73584
G
Generic Name
Desvenlafaxine
Product Specifications
Route of AdministrationORAL
Effective DateMay 29, 2022
FDA Product Classification

INGREDIENTS (13)

MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
D&C RED NO. 27 ALUMINUM LAKEInactive
Code: ZK64F7XSTX
Classification: IACT
DESVENLAFAXINE SUCCINATEActive
Quantity: 100 mg in 1 1
Code: ZB22ENF0XR
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE OXIDE 900000Inactive
Code: 16P9295IIL
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

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Desvenlafaxine - FDA Drug Approval Details