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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209627
Company: THERAPEUTICSMD INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ANNOVERA ETHINYL ESTRADIOL; SEGESTERONE ACETATE 0.013MG/24HR;0.15MG/24HR RING;VAGINAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/10/2018 ORIG-1 Approval Type 1 - New Molecular Entity and Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209627s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209627Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/209627Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/29/2022 SUPPL-3 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209627s003lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/29/2022 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209627s003lbl.pdf
08/10/2018 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209627s000lbl.pdf
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