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Details for New Drug Application (NDA): 021502

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NDA 021502 describes ANTHELIOS SX, which is a drug marketed by Loreal Usa and is included in one NDA. It is available from one supplier. Additional details are available on the ANTHELIOS SX profile page.

The generic ingredient in ANTHELIOS SX is avobenzone; ecamsule; octocrylene. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the avobenzone; ecamsule; octocrylene profile page.

Summary for NDA: 021502

Tradename:
ANTHELIOS SX
Applicant:
Loreal Usa
Ingredient:
avobenzone; ecamsule; octocrylene
Patents:0
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 021502

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ANTHELIOS SX
avobenzone; ecamsule; octocrylene
CREAM;TOPICAL 021502 NDA L'Oreal USA Products Inc 49967-017 49967-017-01 1 TUBE in 1 CARTON (49967-017-01) > 100 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:CREAM;TOPICALStrength2%;2%;10%
Approval Date:Jul 21, 2006TE:RLD:Yes

Expired Orange Book Patents for NDA: 021502

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Loreal Usa
ANTHELIOS SX
avobenzone; ecamsule; octocrylene
CREAM;TOPICAL021502-001Jul 21, 20064,585,597► subscribe
Loreal Usa
ANTHELIOS SX
avobenzone; ecamsule; octocrylene
CREAM;TOPICAL021502-001Jul 21, 20065,587,150► subscribe
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