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Drugs@FDA: FDA-Approved Drugs

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

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

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.html
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/20/2025 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204977s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/204977Orig1s10ltr.pdf
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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
06/20/2025 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204977s010lbl.pdf
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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