Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075787
Company: SUN PHARM INDUSTRIES

• Other Important Information from FDA

Products on ANDA 075787

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075787

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
06/29/2007	SUPPL-12	Labeling		Label is not available on this site.
06/29/2007	SUPPL-11	Labeling		Label is not available on this site.
06/30/2005	SUPPL-4	Labeling		Label is not available on this site.