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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 072575
Company: MYLAN

Products on ANDA 072575

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 072575

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.

Therapeutic Equivalents for ANDA 072575

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	217268	ALEMBIC
PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE;ORAL	Prescription	No	AB	213406	APPCO
PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE;ORAL	Prescription	No	AB	213052	AUROBINDO PHARMA LTD
PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE;ORAL	Prescription	No	AB	214608	GRANULES
PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE;ORAL	Prescription	No	AB	214083	LANNETT CO INC
PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	EQ 5MG BASE	CAPSULE;ORAL	Prescription	No	AB	215697	MANKIND PHARMA
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	217268	ALEMBIC
PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE;ORAL	Prescription	No	AB	213406	APPCO
PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE;ORAL	Prescription	No	AB	213052	AUROBINDO PHARMA LTD
PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE;ORAL	Prescription	No	AB	214608	GRANULES
PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE;ORAL	Prescription	No	AB	214083	LANNETT CO INC
PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	EQ 2MG BASE	CAPSULE;ORAL	Prescription	No	AB	215697	MANKIND PHARMA
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	217268	ALEMBIC
PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE;ORAL	Prescription	No	AB	213406	APPCO
PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE;ORAL	Prescription	No	AB	213052	AUROBINDO PHARMA LTD
PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE;ORAL	Prescription	No	AB	214608	GRANULES
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	214083	LANNETT CO INC
PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	EQ 1MG BASE	CAPSULE;ORAL	Prescription	No	AB	215697	MANKIND PHARMA
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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