Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021501
Company: LOREAL USA

Products on NDA 021501

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CAPITAL SOLEIL 15	AVOBENZONE; ECAMSULE; OCTOCRYLENE	2%;3%;10%	CREAM;TOPICAL	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021501

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/02/2006	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021501s000LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021501_capital_soleil_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/21/2014	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
06/05/2007	SUPPL-3	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021501s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021501s003ltr.pdf
04/24/2007	SUPPL-1	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021501s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021501s001ltr.pdf

Labels for NDA 021501

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/05/2007	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021501s003lbl.pdf
04/24/2007	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021501s001lbl.pdf

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

CAPITAL SOLEIL 15

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

CREAM;TOPICAL; 2%;3%;10%

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
CAPITAL SOLEIL 15	AVOBENZONE; ECAMSULE; OCTOCRYLENE	2%;3%;10%	CREAM;TOPICAL	Over-the-counter	Yes	021501	LOREAL USA