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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204852
Company: AUROBINDO PHARMA

Products on ANDA 204852

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204852

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/05/2020	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 204852

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	071258	APOTEX
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	204852	AUROBINDO PHARMA
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	071196	APOTEX INC
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	204852	AUROBINDO PHARMA
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	204852	AUROBINDO PHARMA
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	204852	AUROBINDO PHARMA
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

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