Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019668
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARDURA DOXAZOSIN MESYLATE EQ 1MG BASE TABLET;ORAL Prescription AB Yes Yes
CARDURA DOXAZOSIN MESYLATE EQ 2MG BASE TABLET;ORAL Prescription AB Yes No
CARDURA DOXAZOSIN MESYLATE EQ 4MG BASE TABLET;ORAL Prescription AB Yes No
CARDURA DOXAZOSIN MESYLATE EQ 8MG BASE TABLET;ORAL Prescription AB Yes 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
11/02/1990 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/09/2016 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019668s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019668Orig1s028ltr.pdf
07/28/2014 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

11/06/2013 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019668s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019668Orig1s026ltr.pdf
01/14/2010 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019668s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019668s022ltr.pdf
07/10/2009 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019668s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019668s021ltr.pdf
02/28/2006 SUPPL-17 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019668s017ltr.pdf
09/13/2002 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

01/23/2002 SUPPL-15 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19668s15ltr.pdf
10/10/2000 SUPPL-14 Labeling

Label is not available on this site.

04/07/2000 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/13/2003 SUPPL-12 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19668slr012ltr.pdf
07/21/1998 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

07/21/1998 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/29/1997 SUPPL-9 Labeling

Label is not available on this site.

09/13/1996 SUPPL-8 Labeling

Label is not available on this site.

02/06/1995 SUPPL-7 Labeling

Label is not available on this site.

07/18/1994 SUPPL-6 Labeling

Label is not available on this site.

10/05/1993 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/29/1993 SUPPL-4 Labeling

Label is not available on this site.

11/02/1992 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/06/1991 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/14/1991 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/09/2016 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019668s028lbl.pdf
11/06/2013 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019668s026lbl.pdf
01/14/2010 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019668s022lbl.pdf
07/10/2009 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019668s021lbl.pdf

CARDURA

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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