Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 202180
Company: TORRENT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 50MG TABLET;ORAL Prescription AB No No
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 100MG TABLET;ORAL Prescription AB No No
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 150MG TABLET;ORAL Prescription AB No No
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 300MG TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/27/2013 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/18/2014 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

06/26/2014 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

TRAZODONE HYDROCHLORIDE

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 206923 ACCORD HLTHCARE
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 071636 ALVOGEN
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 071258 APOTEX
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 072192 OXFORD PHARMS
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 073137 SUN PHARM INDUSTRIES
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 071523 TEVA PHARMS USA
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 202180 TORRENT
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 205253 ZYDUS PHARMS

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 206923 ACCORD HLTHCARE
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 071514 ALVOGEN
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 071196 APOTEX INC
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 072193 OXFORD PHARMS
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 073137 SUN PHARM INDUSTRIES
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 071524 TEVA PHARMS USA
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 202180 TORRENT
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 205253 ZYDUS PHARMS

TABLET;ORAL; 150MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 150MG TABLET;ORAL Prescription No AB 206923 ACCORD HLTHCARE
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 150MG TABLET;ORAL Prescription No AB 071196 APOTEX INC
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 150MG TABLET;ORAL Prescription No AB 071525 PLIVA
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 150MG TABLET;ORAL Prescription No AB 073137 SUN PHARM INDUSTRIES
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 150MG TABLET;ORAL Prescription No AB 202180 TORRENT
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 150MG TABLET;ORAL Prescription No AB 205253 ZYDUS PHARMS

TABLET;ORAL; 300MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 300MG TABLET;ORAL Prescription No AB 206923 ACCORD HLTHCARE
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 300MG TABLET;ORAL Prescription No AB 071196 APOTEX INC
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 300MG TABLET;ORAL Prescription No AB 202180 TORRENT
TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 300MG TABLET;ORAL Prescription No AB 205253 ZYDUS PHARMS

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English