Is there a generic for Avobenzone; ecamsule; octocrylene?

The FDA Orange Book does not currently list an approved generic (ANDA) for Avobenzone; ecamsule; octocrylene. It is available as 2 brand (NDA) applications.

What is the reference-listed drug for Avobenzone; ecamsule; octocrylene?

CAPITAL SOLEIL 15 (NDA 021501, LOREAL USA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Avobenzone; ecamsule; octocrylene are approved?

Avobenzone; ecamsule; octocrylene is approved in the following dosage form: cream.

FDA Orange Book · active-ingredient family

Avobenzone; ecamsule; octocrylene

Avobenzone; ecamsule; octocrylene is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:CAPITAL SOLEIL 15 · NDA 021501

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · cream

Product	Applicant	Application	TE	Approved
CAPITAL SOLEIL 15RLD	LOREAL USA	NDA 021501	—	Oct 02, 2006
ANTHELIOS SXRLD	LOREAL USA	NDA 021502	—	Jul 21, 2006

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Avobenzone; ecamsule; octocrylene — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo