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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077873
Company: AUROBINDO PHARMA USA

Other Important Information from FDA

Products on ANDA 077873

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077873

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/29/2007	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077873s000_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2007/077873Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/06/2026	SUPPL-29	Labeling-Package Insert		Label is not available on this site.
04/06/2026	SUPPL-28	Labeling-Package Insert		Label is not available on this site.
05/04/2021	SUPPL-25	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
05/04/2021	SUPPL-23	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
07/15/2015	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
12/27/2013	SUPPL-20	Labeling-Container/Carton Labels		Label is not available on this site.
12/27/2011	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
06/24/2011	SUPPL-17	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
07/27/2011	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
08/18/2010	SUPPL-14	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
07/02/2010	SUPPL-11	Labeling-Medication Guide, Labeling-Container/Carton Labels		Label is not available on this site.
07/22/2009	SUPPL-5	Labeling		Label is not available on this site.
11/17/2008	SUPPL-3	Labeling		Label is not available on this site.
03/26/2008	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 077873

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	217280	ALEMBIC
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	077873	AUROBINDO PHARMA USA
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	212645	CADILA PHARMS LTD
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213485	CSPC OUYI
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
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	209748	PRINSTON INC
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

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	217280	ALEMBIC
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	077873	AUROBINDO PHARMA USA
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	212645	CADILA PHARMS LTD
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213485	CSPC OUYI
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
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	209748	PRINSTON INC
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

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