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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091427
Company: AUROBINDO PHARMA USA

Products on ANDA 091427

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091427

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/14/2011	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
05/04/2021	SUPPL-11	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
05/04/2021	SUPPL-9	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
07/15/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
12/27/2013	SUPPL-5	Labeling-Container/Carton Labels		Label is not available on this site.
12/27/2011	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
06/24/2011	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091427

PAROXETINE HYDROCHLORIDE

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	091427	AUROBINDO PHARMA USA
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	212645	CADILA PHARMS LTD
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213485	CSPC OUYI
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	209293	SCIECURE PHARMA INC
PAXIL CR	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	020936	APOTEX

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