Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021853
Company: RELIANT PHARMS

Products on NDA 021853

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OMACOR	OMEGA-3ACID ETHYL ESTERS	1G	CAPSULE; ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021853

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/12/2007	ORIG-1	Approval	Type 6 - New Indication (no longer used)	STANDARD	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021853s000, 021654s016ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021853_021654s016_omacor_toc.cfm