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FDA Approval

VENLAFAXINE HYDROCHLORIDE

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company

XLCare Pharmaceuticals, Inc.

DUNS: 080991142

Effective Date

October 29, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Venlafaxine(75 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Ascent Pharmaceuticals, Inc.

Labeler

XLCare Pharmaceuticals, Inc.

DUNS Number

080938961

Products4

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

VENLAFAXINE HYDROCHLORIDE

Product Details

NDC Product Code

72865-198

Application Number

ANDA214419

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 29, 2021

Ingredients

VenlafaxineActive

Code: 7D7RX5A8MOClass: ACTIMQuantity: 75 mg in 1 1

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

CELLULOSE ACETATEInactive

Code: 3J2P07GVB6Class: IACT

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5PClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3BClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

VENLAFAXINE HYDROCHLORIDE

Product Details

NDC Product Code

72865-200

Application Number

ANDA214419

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 29, 2021

Ingredients

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

VenlafaxineActive

Code: 7D7RX5A8MOClass: ACTIMQuantity: 225 mg in 1 1

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5PClass: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3BClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE ACETATEInactive

Code: 3J2P07GVB6Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

VENLAFAXINE HYDROCHLORIDE

Product Details

NDC Product Code

72865-199

Application Number

ANDA214419

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 29, 2021

Ingredients

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

VenlafaxineActive

Code: 7D7RX5A8MOClass: ACTIMQuantity: 150 mg in 1 1

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE ACETATEInactive

Code: 3J2P07GVB6Class: IACT

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5PClass: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3BClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

VENLAFAXINE HYDROCHLORIDE

Product Details

NDC Product Code

72865-197

Application Number

ANDA214419

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 29, 2021

Ingredients

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE ACETATEInactive

Code: 3J2P07GVB6Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

VenlafaxineActive

Code: 7D7RX5A8MOClass: ACTIMQuantity: 37.5 mg in 1 1

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3BClass: IACT

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5PClass: IACT

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