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FDA Approval

Venlafaxine Hydrochloride

CompanyRebel Distributors Corp. (DUNS: 118802834)

Effective Date

September 3, 2009

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Venlafaxine(37.5 mg in 1 1)

Manufacturing Establishments (1)

Rebel Distributors Corp.

Labeler

Rebel Distributors Corp.

DUNS Number

118802834

Products (4)

Venlafaxine Hydrochloride

NDC Product Code

21695-716

Application Number

ANDA076690

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 30, 2007

Ingredients

VenlafaxineActive

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

COLLOIDAL SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

Venlafaxine Hydrochloride

NDC Product Code

21695-719

Application Number

ANDA076690

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 30, 2007

Ingredients

VenlafaxineActive

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

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

COLLOIDAL SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

Venlafaxine Hydrochloride

NDC Product Code

21695-715

Application Number

ANDA076690

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 30, 2007

Ingredients

VenlafaxineActive

Code: 7D7RX5A8MOClass: ACTIMQuantity: 25 mg in 1 1

COLLOIDAL SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

Venlafaxine Hydrochloride

NDC Product Code

21695-720

Application Number

ANDA076690

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 30, 2007

Ingredients

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

VenlafaxineActive

Code: 7D7RX5A8MOClass: ACTIMQuantity: 100 mg in 1 1

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

COLLOIDAL SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

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