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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205060
Company: ASTRAZENECA

Products on NDA 205060

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EPANOVA	OMEGA-3-CARBOXYLIC ACIDS	1GM CONTAINS AT LEAST 850MG OF POLYUNSATURATED FATTY ACIDS	CAPSULE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205060

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/05/2014	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205060s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205060Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205060Orig1EpanovaTOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/09/2017	SUPPL-6	Labeling		Label is not available on this site.
12/30/2016	SUPPL-4	Manufacturing (CMC)-Packaging	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205060Orig1s004ltr.pdf
03/09/2017	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205060s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205060Orig1s003ltr.pdf
10/07/2016	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205060s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205060Orig1s002ltr.pdf
05/27/2016	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 205060

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/09/2017	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205060s003lbl.pdf
10/07/2016	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205060s002lbl.pdf
05/05/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205060s000lbl.pdf

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