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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206255
Company: GALDERMA LABS LP

Summary Review

Products on NDA 206255

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SOOLANTRA	IVERMECTIN	1%	CREAM;TOPICAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 206255

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
10/14/2022	SUPPL-9	Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206255s005s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/206255Orig1s005,s009ltr.pdf
10/14/2022	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206255s005s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/206255Orig1s005,s009ltr.pdf
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

Labels for NDA 206255

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/14/2022	SUPPL-9	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206255s005s009lbl.pdf
10/14/2022	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206255s005s009lbl.pdf
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

Therapeutic Equivalents for NDA 206255

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	PADAGIS ISRAEL
IVERMECTIN	IVERMECTIN	1%	CREAM;TOPICAL	Prescription	No	AB	210019	TEVA PHARMS USA
IVERMECTIN	IVERMECTIN	1%	CREAM;TOPICAL	Prescription	No	AB	215210	ZYDUS LIFESCIENCES
SOOLANTRA	IVERMECTIN	1%	CREAM;TOPICAL	Prescription	Yes	AB	206255	GALDERMA LABS LP

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