Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021103
Company: NOVO NORDISK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACTIVELLA ESTRADIOL; NORETHINDRONE ACETATE 1MG/0.5MG TABLET; ORAL Prescription 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
04/11/2000 ORIG-1 Approval Type 6 - New Indication (no longer used) STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21103lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21103ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-103_Activella.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/11/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21103lbl.pdf

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