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Details for New Drug Application (NDA): 207071
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NDA 207071 describes FINACEA, which is a drug marketed by Leo Pharma As and is included in two NDAs. It is available from four suppliers. There are nine patents protecting this drug and two Paragraph IV challenges. Additional details are available on the FINACEA profile page.
The generic ingredient in FINACEA is azelaic acid. There are eight drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the azelaic acid profile page.
The generic ingredient in FINACEA is azelaic acid. There are eight drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the azelaic acid profile page.
Summary for 207071
| Tradename: | FINACEA |
| Applicant: | Leo Pharma As |
| Ingredient: | azelaic acid |
| Patents: | 9 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 207071
| Physiological Effect | Decreased Protein Synthesis Decreased Sebaceous Gland Activity |
Suppliers and Packaging for NDA: 207071
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FINACEA | azelaic acid | AEROSOL, FOAM;TOPICAL | 207071 | NDA | LEO Pharma Inc. | 50222-303 | 50222-303-50 | 1 CAN in 1 CARTON (50222-303-50) > 50 g in 1 CAN |
| FINACEA | azelaic acid | AEROSOL, FOAM;TOPICAL | 207071 | NDA | LEO Pharma Inc. | 50222-303 | 50222-303-91 | 1 CAN in 1 CARTON (50222-303-91) > 15 g in 1 CAN |
Paragraph IV (Patent) Challenges for 207071
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| FINACEA | AEROSOL, FOAM;TOPICAL | azelaic acid | 207071 | 2017-09-14 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, FOAM;TOPICAL | Strength | 15% | ||||
| Approval Date: | Jul 29, 2015 | TE: | RLD: | Yes | |||||
| Patent: | Start Trial | Patent Expiration: | Oct 18, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TOPICAL TREATMENT OF INFLAMMATORY PAPULES AND PUSTULES OF MILD TO MODERATE ROSACEA | ||||||||
| Patent: | Start Trial | Patent Expiration: | Oct 24, 2023 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | Start Trial | Patent Expiration: | Sep 8, 2019 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 207071
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Leo Pharma As | FINACEA | azelaic acid | AEROSOL, FOAM;TOPICAL | 207071-001 | Jul 29, 2015 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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