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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 215650
Company: DARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
XACIATO CLINDAMYCIN PHOSPHATE EQ 2% BASE GEL;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
12/07/2021 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215650s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/215650Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/215650Orig1s000TOC.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/07/2021 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215650s000lbl.pdf
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