Clinical Trials

Find trials by condition, location & phase

Drug Monographs

Browse drug monographs and information

Explore organizations and their profiles

Latest updates on trials and healthcare

Approved products by global authorities

AI-Powered Research

Discover powerful insights with advanced AI analysis tools for clinical trials.

Premium Access

Get unlimited access to our comprehensive pharmaceutical database and analytics.

FDA Approval

Nefazodone Hydrochloride

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

FDA Approval Summary

Company

Teva Pharmaceuticals USA, Inc.

DUNS: 001627975

Effective Date

November 16, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Nefazodone(100 mg in 1 1)

Products5

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

Nefazodone Hydrochloride

Product Details

NDC Product Code

0093-1024

Application Number

ANDA076037

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 16, 2021

Ingredients

NefazodoneActive

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

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

Nefazodone Hydrochloride

Product Details

NDC Product Code

0093-7178

Application Number

ANDA076037

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 16, 2021

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

NefazodoneActive

Code: 27X63J94GRClass: ACTIBQuantity: 50 mg in 1 1

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

Nefazodone Hydrochloride

Product Details

NDC Product Code

0093-7113

Application Number

ANDA076037

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 16, 2021

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

NefazodoneActive

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

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

Nefazodone Hydrochloride

Product Details

NDC Product Code

0093-1026

Application Number

ANDA076037

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 16, 2021

Ingredients

NefazodoneActive

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

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

Nefazodone Hydrochloride

Product Details

NDC Product Code

0093-1025

Application Number

ANDA076037

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 16, 2021

Ingredients

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

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

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

© Copyright 2025. All Rights Reserved by MedPath

Home Terms & Conditions Privacy Policy