Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209457
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ICOSAPENT ETHYL ICOSAPENT ETHYL 1GM CAPSULE;ORAL Prescription AB 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
05/21/2020 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209457Orig1s000ltr.pdf

ICOSAPENT ETHYL

CAPSULE;ORAL; 1GM
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ICOSAPENT ETHYL ICOSAPENT ETHYL 1GM CAPSULE;ORAL Prescription No AB 209457 HIKMA
VASCEPA ICOSAPENT ETHYL 1GM CAPSULE;ORAL Prescription Yes AB 202057 AMARIN PHARMS

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