Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077668
Company: NORVIUM BIOSCIENCE

Products on ANDA 077668

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077668

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/28/2007	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
07/17/2014	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/077668s006lbl.pdf
02/13/2009	SUPPL-4	Labeling		Label is not available on this site.
04/06/2009	SUPPL-3	Labeling		Label is not available on this site.
09/24/2008	SUPPL-2	Labeling		Label is not available on this site.
10/22/2007	SUPPL-1	Labeling		Label is not available on this site.

Labels for ANDA 077668

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/17/2014	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/077668s006lbl.pdf