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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210107
Company: ZYDUS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OMEGA-3-ACID ETHYL ESTERS OMEGA-3-ACID ETHYL ESTERS 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS CAPSULE;ORAL Discontinued None No 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
06/14/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/06/2021 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

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