Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022408
Company: CIPHER
Company: CIPHER
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NATROBA | SPINOSAD | 0.9% | SUSPENSION;TOPICAL | 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 |
---|---|---|---|---|---|---|---|
01/18/2011 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022408lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022408s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022408sOrig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022408Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/28/2021 | SUPPL-10 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022408Orig1s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022408Orig1s010ltr.pdf | |
04/28/2021 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
12/30/2014 | SUPPL-5 | Efficacy-Pediatric |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022408s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022408Orig1s005ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/28/2021 | SUPPL-10 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022408Orig1s010lbl.pdf | |
12/30/2014 | SUPPL-5 | Efficacy-Pediatric | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022408s005lbl.pdf | |
01/18/2011 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022408lbl.pdf |