Details for New Drug Application (NDA): 022009
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NDA 022009 describes ANTHELIOS 40, which is a drug marketed by Loreal Usa and is included in one NDA. Additional details are available on the ANTHELIOS 40 profile page.
The generic ingredient in ANTHELIOS 40 is avobenzone; ecamsule; octocrylene; titanium dioxide. There are two drug master file entries for this compound. Additional details are available on the avobenzone; ecamsule; octocrylene; titanium dioxide profile page.
The generic ingredient in ANTHELIOS 40 is avobenzone; ecamsule; octocrylene; titanium dioxide. There are two drug master file entries for this compound. Additional details are available on the avobenzone; ecamsule; octocrylene; titanium dioxide profile page.
Summary for 022009
| Tradename: | ANTHELIOS 40 |
| Applicant: | Loreal Usa |
| Ingredient: | avobenzone; ecamsule; octocrylene; titanium dioxide |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | CREAM;TOPICAL | Strength | 2%;3%;10%;5% | ||||
| Approval Date: | Mar 31, 2008 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | CREAM;TOPICAL | Strength | 2%;3%;10%;5% | ||||
| Approval Date: | Oct 29, 2009 | TE: | RLD: | Yes | |||||
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