Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022408
Company: PARAPRO LLC
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
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
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

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