Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206255
Company: GALDERMA LABS LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SOOLANTRA IVERMECTIN 1% CREAM;TOPICAL Prescription AB 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
12/19/2014 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/2014/206255lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206255Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206255Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206255Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/19/2018 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206255s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206255Orig1s004ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/19/2018 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206255s004lbl.pdf
12/19/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206255lbl.pdf

SOOLANTRA

CREAM;TOPICAL; 1%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IVERMECTIN IVERMECTIN 1% CREAM;TOPICAL Prescription No AB 210225 PERRIGO UK FINCO
IVERMECTIN IVERMECTIN 1% CREAM;TOPICAL Prescription No AB 210019 TEVA PHARMS USA
SOOLANTRA IVERMECTIN 1% CREAM;TOPICAL Prescription Yes AB 206255 GALDERMA LABS LP

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