Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022009
Company: LOREAL USA

• Summary Review

Products on NDA 022009

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ANTHELIOS 40	AVOBENZONE; ECAMSULE; OCTOCRYLENE; TITANIUM DIOXIDE	2%;3%;10%;5%	CREAM;TOPICAL	Over-the-counter	None	Yes	Yes
ANTHELIOS 40	AVOBENZONE; ECAMSULE; OCTOCRYLENE; TITANIUM DIOXIDE	2%;3%;10%;5%	CREAM;TOPICAL	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022009

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/31/2008	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Letter (PDF) Review Summary Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022009s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022009_avobenzone_ecamsule_octocrylene_titanium_dioxide_cream_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022009s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/21/2014	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
04/09/2010	SUPPL-4	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022009s004ltr.pdf
10/29/2009	SUPPL-2	Efficacy-Manufacturing Change With Clinical Data		Label is not available on this site.
10/21/2008	SUPPL-1	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022009s001ltr.pdf

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

ANTHELIOS 40

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%;5%

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
ANTHELIOS 40	AVOBENZONE; ECAMSULE; OCTOCRYLENE; TITANIUM DIOXIDE	2%;3%;10%;5%	CREAM;TOPICAL	Over-the-counter	Yes	022009	LOREAL USA

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%;5%

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
ANTHELIOS 40	AVOBENZONE; ECAMSULE; OCTOCRYLENE; TITANIUM DIOXIDE	2%;3%;10%;5%	CREAM;TOPICAL	Over-the-counter	Yes	022009	LOREAL USA