Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072575
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE EQ 5MG BASE CAPSULE;ORAL Prescription AB No No
PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE EQ 2MG BASE CAPSULE;ORAL Prescription AB No No
PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE EQ 1MG BASE CAPSULE;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
02/28/1989 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/17/2015 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

11/17/2015 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

03/31/2011 SUPPL-13 Labeling-Container/Carton Labels

Label is not available on this site.

06/03/2002 SUPPL-8 Labeling

Label is not available on this site.

08/01/2000 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/25/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/05/1998 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/15/1993 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/04/1990 SUPPL-2 Labeling

Label is not available on this site.

01/31/1990 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

PRAZOSIN HYDROCHLORIDE

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 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

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

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