Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204134
Company: LUPIN LTD

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 12.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 25MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 37.5MG BASE TABLET, EXTENDED RELEASE;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
01/20/2017 ORIG-1 Approval

Label is not available on this site.

PAROXETINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; EQ 12.5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 12.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204744 LANNETT CO INC
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 12.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204134 LUPIN LTD
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 12.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 077873 MYLAN
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 12.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 209293 SCIECURE PHARMA INC
PAXIL CR PAROXETINE HYDROCHLORIDE EQ 12.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 020936 APOTEX TECHNOLOGIES

TABLET, EXTENDED RELEASE;ORAL; EQ 25MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 25MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204744 LANNETT CO INC
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 25MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204134 LUPIN LTD
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 25MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 077873 MYLAN
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 25MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 209293 SCIECURE PHARMA INC
PAXIL CR PAROXETINE HYDROCHLORIDE EQ 25MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 020936 APOTEX TECHNOLOGIES

TABLET, EXTENDED RELEASE;ORAL; EQ 37.5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 37.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204744 LANNETT CO INC
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 37.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204134 LUPIN LTD
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 37.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091427 MYLAN
PAROXETINE HYDROCHLORIDE PAROXETINE HYDROCHLORIDE EQ 37.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 209293 SCIECURE PHARMA INC
PAXIL CR PAROXETINE HYDROCHLORIDE EQ 37.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 020936 APOTEX TECHNOLOGIES

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