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Abbreviated New Drug Application (ANDA): 075509
Company: AUROBINDO PHARMA USA

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
10/19/2000 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75509ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/21/2017 SUPPL-18 Labeling-Package Insert

Label is not available on this site.
09/22/2014 SUPPL-17 Labeling-Package Insert

Label is not available on this site.
02/24/2015 SUPPL-16 Labeling-Package Insert

Label is not available on this site.
07/08/2011 SUPPL-15 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.
10/01/2007 SUPPL-8 Labeling

Label is not available on this site.
01/21/2004 SUPPL-3 Labeling

Label is not available on this site.
03/25/2002 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 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
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