FDA Orange Book · active-ingredient family
Avobenzone; ecamsule; octocrylene
Avobenzone; ecamsule; octocrylene: 2 brands, 0 generics; first approved Jul 21, 2006.
Brand only
Generic status & protection
No listed patents or exclusivity — brand product(s) only.
Brands (NDA)
2
Generics (ANDA)
0
Listed patents
0
Presentations
2
Originator applications
Brand (NDA) products
LOREAL USANDA 0215012006
LOREAL USANDA 0215012006
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 2%;3%;10% | CREAM | TOPICAL | OTC | — |
LOREAL USANDA 0215022006
LOREAL USANDA 0215022006
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 2%;2%;10% | CREAM | TOPICAL | OTC | — |
Orange Book patent file
Listed patents
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.
FDA approval span
Approval history
First approval
Jul 21, 2006
20 yr 3 mo ago
Most recent approval
Oct 02, 2006
20 yr 1 mo ago
All 2 applications were approved in 2006.
Brand (NDA) 2100%
Generic (ANDA) 00%
Avobenzone; ecamsule; octocrylene — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
