Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077035
Company: FOSUN PHARMA

• Other Important Information from FDA

Products on ANDA 077035

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 077035

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/28/2004	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/77035ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/28/2013	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
12/18/2012	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/28/2009	SUPPL-9	Labeling		Label is not available on this site.
10/19/2007	SUPPL-8	Labeling		Label is not available on this site.
10/19/2007	SUPPL-6	Labeling		Label is not available on this site.
08/01/2005	SUPPL-5	Labeling		Label is not available on this site.
05/11/2005	SUPPL-4	Labeling		Label is not available on this site.