Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 005490
Company: ORGANON USA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LYNORAL ETHINYL ESTRADIOL 0.05MG TABLET;ORAL Discontinued None No No
LYNORAL ETHINYL ESTRADIOL 0.01MG TABLET;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
04/13/1944 ORIG-1 Approval UNKNOWN

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