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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205253
Company: ZYDUS PHARMS

Products on ANDA 205253

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 205253

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/10/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/29/2024	SUPPL-21	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
10/18/2022	SUPPL-18	Labeling-Container/Carton Labels		Label is not available on this site.
10/30/2020	SUPPL-8	Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Patient Package Insert		Label is not available on this site.
04/20/2020	SUPPL-4	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 205253

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	211116	CROSSMEDIKA SA
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	218988	GRANULES
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	217740	GRAVITI PHARMS
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	211116	CROSSMEDIKA SA
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	218988	GRANULES
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	217740	GRAVITI PHARMS
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	211116	CROSSMEDIKA SA
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	150MG	TABLET;ORAL	Prescription	No	AB	218988	GRANULES
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	150MG	TABLET;ORAL	Prescription	No	AB	217740	GRAVITI PHARMS
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	211116	CROSSMEDIKA SA
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	300MG	TABLET;ORAL	Prescription	No	AB	218988	GRANULES
TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	300MG	TABLET;ORAL	Prescription	No	AB	217740	GRAVITI PHARMS
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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