Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077601
Company: PHARM ASSOC

• Other Important Information from FDA

Products on ANDA 077601

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CITALOPRAM HYDROBROMIDE	CITALOPRAM HYDROBROMIDE	EQ 10MG BASE/5ML	SOLUTION;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077601

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/15/2005	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
08/18/2023	SUPPL-9	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/21/2021	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
09/13/2021	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
01/04/2017	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
07/07/2015	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
07/17/2014	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
07/11/2014	SUPPL-3	Labeling-Package Insert		Label is not available on this site.