Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076968
Company: OXFORD PHARMS

Products on ANDA 076968

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	AB	No	No
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	AB	No	No
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET;ORAL	Prescription	AB	No	No
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076968

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/21/2010	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
06/28/2023	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
06/28/2023	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076968

PAROXETINE HYDROCHLORIDE

TABLET;ORAL; EQ 10MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PAROXETINE	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	203854	PRINSTON INC
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	075356	APOTEX
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	078406	AUROBINDO PHARMA
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	076618	CHARTWELL RX
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	078902	MYLAN
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	076968	OXFORD PHARMS
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	211248	YILING
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	077584	ZYDUS PHARMS USA
PAXIL	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	Yes	AB	020031	APOTEX

TABLET;ORAL; EQ 20MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PAROXETINE	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	203854	PRINSTON INC
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	075356	APOTEX
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	078406	AUROBINDO PHARMA
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	076618	CHARTWELL RX
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	078902	MYLAN
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	076968	OXFORD PHARMS
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	211248	YILING
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	077584	ZYDUS PHARMS USA
PAXIL	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	Yes	AB	020031	APOTEX

TABLET;ORAL; EQ 30MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PAROXETINE	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET;ORAL	Prescription	No	AB	203854	PRINSTON INC
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET;ORAL	Prescription	No	AB	075356	APOTEX
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET;ORAL	Prescription	No	AB	078406	AUROBINDO PHARMA
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET;ORAL	Prescription	No	AB	076618	CHARTWELL RX
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET;ORAL	Prescription	No	AB	078902	MYLAN
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET;ORAL	Prescription	No	AB	076968	OXFORD PHARMS
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET;ORAL	Prescription	No	AB	211248	YILING
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET;ORAL	Prescription	No	AB	077584	ZYDUS PHARMS USA
PAXIL	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET;ORAL	Prescription	Yes	AB	020031	APOTEX

TABLET;ORAL; EQ 40MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PAROXETINE	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET;ORAL	Prescription	No	AB	203854	PRINSTON INC
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET;ORAL	Prescription	No	AB	075356	APOTEX
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET;ORAL	Prescription	No	AB	078406	AUROBINDO PHARMA
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET;ORAL	Prescription	No	AB	076618	CHARTWELL RX
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET;ORAL	Prescription	No	AB	078902	MYLAN
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET;ORAL	Prescription	No	AB	076968	OXFORD PHARMS
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET;ORAL	Prescription	No	AB	211248	YILING
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET;ORAL	Prescription	No	AB	077584	ZYDUS PHARMS USA
PAXIL	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET;ORAL	Prescription	Yes	AB	020031	APOTEX