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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075580
Company: APOTEX

Products on ANDA 075580

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 075580

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/18/2000	ORIG-1	Approval			Letter (PDF) Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75580ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75580ta.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/27/2024	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
09/27/2024	SUPPL-24	Labeling-Patient Package Insert, Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
02/21/2017	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
09/21/2014	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
09/21/2014	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
06/07/2006	SUPPL-14	Labeling		Label is not available on this site.
01/31/2006	SUPPL-13	Labeling		Label is not available on this site.
03/18/2005	SUPPL-11	Labeling		Label is not available on this site.
08/28/2002	SUPPL-4	Labeling		Label is not available on this site.
01/24/2002	SUPPL-3	Manufacturing (CMC)-Packaging		Label is not available on this site.
09/21/2001	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
01/19/2001	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075580

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	075509	AUROBINDO PHARMA USA
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	205210	HERITAGE PHARMA
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	212727	RISING
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	209013	SOMERSET THERAPS LLC
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	212329	UNICHEM
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	075509	AUROBINDO PHARMA USA
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	205210	HERITAGE PHARMA
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	212727	RISING
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	209013	SOMERSET THERAPS LLC
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	212329	UNICHEM
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	075509	AUROBINDO PHARMA USA
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET;ORAL	Prescription	No	AB	205210	HERITAGE PHARMA
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET;ORAL	Prescription	No	AB	212727	RISING
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET;ORAL	Prescription	No	AB	209013	SOMERSET THERAPS LLC
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	212329	UNICHEM
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	075509	AUROBINDO PHARMA USA
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET;ORAL	Prescription	No	AB	205210	HERITAGE PHARMA
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET;ORAL	Prescription	No	AB	212727	RISING
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET;ORAL	Prescription	No	AB	209013	SOMERSET THERAPS LLC
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	212329	UNICHEM
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET;ORAL	Prescription	No	AB	208719	ZYDUS PHARMS

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