Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202736
Company: ARBOR PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SKLICE IVERMECTIN 0.5% LOTION;TOPICAL Over-the-counter 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
02/07/2012 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202736Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202736s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202736_sklice_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202736Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/27/2020 SUPPL-6 Efficacy-Rx To OTC Switch Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202736Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202736Orig1s006ltr.pdf
06/16/2017 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202736s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202736Orig1s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/27/2020 SUPPL-6 Efficacy-Rx To OTC Switch Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202736Orig1s006lbl.pdf
06/16/2017 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202736s003lbl.pdf
02/07/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202736Orig1s000lbl.pdf

SKLICE

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

LOTION;TOPICAL; 0.5%
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
SKLICE IVERMECTIN 0.5% LOTION;TOPICAL Over-the-counter Yes 202736 ARBOR PHARMS LLC

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