Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017442
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MINIPRESS PRAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE;ORAL Prescription AB Yes No
MINIPRESS PRAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE;ORAL Prescription AB Yes No
MINIPRESS PRAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/23/1976 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/08/2016 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

02/27/2015 SUPPL-43 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017442 s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017442Orig1s043ltr.pdf
07/28/2014 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

11/04/2013 SUPPL-41 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017442s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017442Orig1s041ltr.pdf
07/10/2009 SUPPL-35 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017442s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017442s035ltr.pdf
04/06/2009 SUPPL-33 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017442s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017442s033ltr.pdf
06/12/2001 SUPPL-29 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17442s29ltr.pdf
05/10/1994 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

05/01/1989 SUPPL-27 Labeling

Label is not available on this site.

08/21/1989 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

10/14/1988 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

08/29/1988 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/14/1987 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

06/06/1988 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

09/27/1985 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

04/25/1986 SUPPL-20 Labeling

Label is not available on this site.

02/26/1985 SUPPL-19 Labeling

Label is not available on this site.

08/13/1984 SUPPL-18 Labeling

Label is not available on this site.

09/13/1984 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/03/1984 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/01/1984 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/29/1983 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

04/25/1986 SUPPL-13 Labeling

Label is not available on this site.

02/19/1982 SUPPL-12 Labeling

Label is not available on this site.

02/19/1982 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

11/17/1981 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

09/25/1981 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/30/1981 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/14/1981 SUPPL-7 Labeling

Label is not available on this site.

01/10/1979 SUPPL-5 Labeling

Label is not available on this site.

08/06/1982 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/27/1978 SUPPL-3 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/14/1977 SUPPL-2 Labeling

Label is not available on this site.

07/13/1977 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/27/2015 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017442 s043lbl.pdf
11/04/2013 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017442s041lbl.pdf
07/10/2009 SUPPL-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017442s035lbl.pdf
04/06/2009 SUPPL-33 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017442s033lbl.pdf

MINIPRESS

CAPSULE;ORAL; EQ 5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MINIPRESS PRAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE;ORAL Prescription Yes AB 017442 PFIZER
PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE;ORAL Prescription No AB 072575 MYLAN
PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE;ORAL Prescription No AB 210971 NOVITIUM PHARMA
PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE;ORAL Prescription No AB 071745 TEVA PHARMS

CAPSULE;ORAL; EQ 1MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MINIPRESS PRAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE;ORAL Prescription Yes AB 017442 PFIZER
PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE;ORAL Prescription No AB 071994 IVAX SUB TEVA PHARMS
PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE;ORAL Prescription No AB 072575 MYLAN
PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE;ORAL Prescription No AB 210971 NOVITIUM PHARMA
PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE;ORAL Prescription No AB 071745 TEVA PHARMS

CAPSULE;ORAL; EQ 2MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MINIPRESS PRAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE;ORAL Prescription Yes AB 017442 PFIZER
PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE;ORAL Prescription No AB 072575 MYLAN
PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE;ORAL Prescription No AB 210971 NOVITIUM PHARMA
PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE;ORAL Prescription No AB 071745 TEVA PHARMS
PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE;ORAL Prescription No AB 071995 TEVA PHARMS

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