An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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
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	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	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	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	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	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	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	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	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	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	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	209013	UPSHER SMITH LABS
DOXAZOSIN MESYLATE	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET;ORAL	Prescription	No	AB	208719	ZYDUS PHARMS

Top