Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076922
Company: STRIDES PHARMA INTL

• Other Important Information from FDA

Products on ANDA 076922

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE;ORAL	Discontinued	None	No	No
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE;ORAL	Discontinued	None	No	No
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076922

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/16/2004	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
12/20/2023	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
12/20/2023	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
12/20/2023	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
12/17/2015	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
09/16/2014	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
02/28/2012	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
02/28/2012	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
03/25/2010	SUPPL-4	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
03/25/2010	SUPPL-3	Labeling		Label is not available on this site.
09/25/2008	SUPPL-2	Labeling		Label is not available on this site.
09/15/2005	SUPPL-1	Labeling		Label is not available on this site.