Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 202736
Company: ARBOR PHARMS LLC
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 |
---|---|---|---|---|---|
05/28/2021 | SUPPL-9 |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202736Orig1s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202736Orig1s009ltr.pdf | ||
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 |
---|---|---|---|---|---|
05/28/2021 | SUPPL-9 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202736Orig1s009lbl.pdf | |
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 |
---|---|---|---|---|---|---|---|
IVERMECTIN | IVERMECTIN | 0.5% | LOTION;TOPICAL | Over-the-counter | No | 210720 | TARO |
SKLICE | IVERMECTIN | 0.5% | LOTION;TOPICAL | Over-the-counter | Yes | 202736 | ARBOR PHARMS LLC |