Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077395
Company: APOTEX INC

• Other Important Information from FDA

Products on ANDA 077395

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SUSPENSION;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077395

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/04/2006	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/077395.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/13/2025	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
07/08/2024	SUPPL-15	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
03/31/2022	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
03/31/2022	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
03/17/2020	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
01/19/2015	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
01/19/2015	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
01/31/2013	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
03/05/2010	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
05/07/2009	SUPPL-7	Labeling		Label is not available on this site.
05/07/2009	SUPPL-6	Labeling		Label is not available on this site.
12/15/2008	SUPPL-5	Labeling		Label is not available on this site.
07/09/2007	SUPPL-2	Labeling		Label is not available on this site.
07/09/2007	SUPPL-1	Labeling		Label is not available on this site.