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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210971
Company: NOVITIUM PHARMA

Products on ANDA 210971

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PRAZOSIN HYDROCHLORIDE	PRAZOSIN HYDROCHLORIDE	EQ 1MG 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 5MG BASE	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210971

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/03/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 210971

PRAZOSIN HYDROCHLORIDE

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

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 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

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