Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075807
Company: REGCON HOLDINGS

• Other Important Information from FDA

Products on ANDA 075807

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 075807

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
01/31/2006	SUPPL-7	Labeling		Label is not available on this site.
06/07/2005	SUPPL-5	Labeling		Label is not available on this site.
06/07/2005	SUPPL-4	Labeling		Label is not available on this site.
09/13/2004	SUPPL-1	Labeling		Label is not available on this site.