Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207139
Company: ACTAVIS LABS FL INC

Products on ANDA 207139

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PAROXETINE MESYLATE	PAROXETINE MESYLATE	EQ 7.5MG BASE	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207139

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/20/2017	ORIG-1	Approval		STANDARD	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207139Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207139Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/25/2023	SUPPL-2	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 207139

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/20/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207139Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 207139

PAROXETINE MESYLATE

CAPSULE;ORAL; EQ 7.5MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BRISDELLE	PAROXETINE MESYLATE	EQ 7.5MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	204516	LEGACY PHARMA
PAROXETINE MESYLATE	PAROXETINE MESYLATE	EQ 7.5MG BASE	CAPSULE;ORAL	Prescription	No	AB	207139	ACTAVIS LABS FL INC
PAROXETINE MESYLATE	PAROXETINE MESYLATE	EQ 7.5MG BASE	CAPSULE;ORAL	Prescription	No	AB	207188	PRINSTON INC