Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077037
Company: MYLAN PHARMS INC

• Other Important Information from FDA

Products on ANDA 077037

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077037

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/05/2004	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
03/30/2009	SUPPL-5	Labeling		Label is not available on this site.
09/24/2008	SUPPL-4	Labeling		Label is not available on this site.
10/22/2007	SUPPL-3	Labeling		Label is not available on this site.
02/14/2006	SUPPL-2	Labeling		Label is not available on this site.
08/01/2005	SUPPL-1	Labeling		Label is not available on this site.