Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076024
Company: FOSUN PHARMA

• Other Important Information from FDA

Products on ANDA 076024

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076024

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/29/2002	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
12/05/2023	SUPPL-7	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/20/2021	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
08/24/2021	SUPPL-5	Labeling-Medication Guide		Label is not available on this site.
01/13/2017	SUPPL-4	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
01/12/2017	SUPPL-3	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/17/2014	SUPPL-2	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.