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FDA Approval

Nefazodone Hydrochloride

CompanyRebel Distributors Corp (DUNS: 118802834)

Effective Date

December 29, 2010

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Nefazodone(200 mg in 1 1)

Manufacturing Establishments (1)

Rebel Distributors Corp

Labeler

Rebel Distributors Corp

DUNS Number

118802834

Products (4)

Nefazodone Hydrochloride

NDC Product Code

21695-176

Application Number

ANDA076037

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 29, 2006

Ingredients

NefazodoneActive

Code: 27X63J94GRClass: ACTIBQuantity: 200 mg in 1 1

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

magnesium stearateInactive

Code: 70097M6I30Class: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

Nefazodone Hydrochloride

NDC Product Code

21695-175

Application Number

ANDA076037

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 29, 2006

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

NefazodoneActive

Code: 27X63J94GRClass: ACTIBQuantity: 150 mg in 1 1

magnesium stearateInactive

Code: 70097M6I30Class: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

Nefazodone Hydrochloride

NDC Product Code

21695-174

Application Number

ANDA076037

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 29, 2006

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

NefazodoneActive

Code: 27X63J94GRClass: ACTIBQuantity: 100 mg in 1 1

magnesium stearateInactive

Code: 70097M6I30Class: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

Nefazodone Hydrochloride

NDC Product Code

21695-177

Application Number

ANDA076037

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 29, 2006

Ingredients

NefazodoneActive

Code: 27X63J94GRClass: ACTIBQuantity: 250 mg in 1 1

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

magnesium stearateInactive

Code: 70097M6I30Class: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

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