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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204977
Company: OSMOTICA PHARM US

Products on NDA 204977

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OMTRYG	OMEGA-3-ACID ETHYL ESTERS TYPE A	1.2GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204977

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/23/2014	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204977Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204977s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204977Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/06/2017	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
07/22/2016	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
03/18/2016	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204977s006lbl.pdf
10/26/2015	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
09/02/2015	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
11/11/2014	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
10/30/2014	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 204977

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/18/2016	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204977s006lbl.pdf
04/23/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204977Orig1s000ltr.pdf

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