Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077469
Company: SANDOZ

• Other Important Information from FDA

• Other Important Information from FDA

Products on ANDA 077469

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077469

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/17/2008	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
08/18/2023	SUPPL-18	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/15/2023	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
08/15/2023	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
01/04/2017	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
05/05/2016	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
07/31/2015	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
12/15/2009	SUPPL-5	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
12/15/2009	SUPPL-2	Labeling		Label is not available on this site.