Drugs@FDA: FDA Approved Drug Products

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

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 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

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

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