Drugs@FDA: FDA Approved Drug Products

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

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 PFIZER
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 075432 ANI PHARMS INC
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 076161 DAVA PHARMS INC
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 075509 MYLAN
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 PFIZER
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 075432 ANI PHARMS INC
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 076161 DAVA PHARMS INC
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 075509 MYLAN
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 PFIZER
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 075432 ANI PHARMS INC
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 076161 DAVA PHARMS INC
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 075509 MYLAN
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 PFIZER
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 075432 ANI PHARMS INC
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 076161 DAVA PHARMS INC
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 075509 MYLAN
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

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