Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208719
Company: ZYDUS PHARMS

Products on ANDA 208719

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET;ORAL	Prescription	AB	No	No
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET;ORAL	Prescription	AB	No	No
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET;ORAL	Prescription	AB	No	No
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208719

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/07/2017	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208719Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 208719

DOXAZOSIN MESYLATE

TABLET;ORAL; EQ 1MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CARDURA	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET;ORAL	Prescription	Yes	AB	019668	VIATRIS
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	202824	ACCORD HLTHCARE
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	075580	APOTEX
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	212727	PHARMGEN
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	075750	PLIVA
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	075536	TEVA
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	209013	UPSHER SMITH LABS
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	208719	ZYDUS PHARMS

TABLET;ORAL; EQ 2MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CARDURA	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET;ORAL	Prescription	Yes	AB	019668	VIATRIS
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	202824	ACCORD HLTHCARE
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	075580	APOTEX
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	212727	PHARMGEN
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	075750	PLIVA
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	075536	TEVA
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	209013	UPSHER SMITH LABS
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	208719	ZYDUS PHARMS

TABLET;ORAL; EQ 4MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CARDURA	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET;ORAL	Prescription	Yes	AB	019668	VIATRIS
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET;ORAL	Prescription	No	AB	202824	ACCORD HLTHCARE
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET;ORAL	Prescription	No	AB	075580	APOTEX
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET;ORAL	Prescription	No	AB	212727	PHARMGEN
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET;ORAL	Prescription	No	AB	075750	PLIVA
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET;ORAL	Prescription	No	AB	075536	TEVA
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET;ORAL	Prescription	No	AB	209013	UPSHER SMITH LABS
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET;ORAL	Prescription	No	AB	208719	ZYDUS PHARMS

TABLET;ORAL; EQ 8MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CARDURA	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET;ORAL	Prescription	Yes	AB	019668	VIATRIS
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET;ORAL	Prescription	No	AB	202824	ACCORD HLTHCARE
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET;ORAL	Prescription	No	AB	075580	APOTEX
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET;ORAL	Prescription	No	AB	212727	PHARMGEN
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET;ORAL	Prescription	No	AB	075750	PLIVA
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET;ORAL	Prescription	No	AB	075536	TEVA
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET;ORAL	Prescription	No	AB	209013	UPSHER SMITH LABS
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET;ORAL	Prescription	No	AB	208719	ZYDUS PHARMS