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Details for New Drug Application (NDA): 207071
NDA 207071 describes FINACEA , which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from four suppliers. There are seven patents protecting this drug. 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. Five 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. Five suppliers are listed for this compound. Additional details are available on the azelaic acid profile page.
Summary for 207071
| Tradename: | FINACEA |
| Applicant: | Bayer Hlthcare |
| Ingredient: | azelaic acid |
| Patents: | 7 |
| Therapeutic Class: | Dermatological Agents |
| 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 | Bayer HealthCare Pharmaceuticals Inc. | 50419-829 | N | 50419-829-71 |
| FINACEA | azelaic acid | AEROSOL, FOAM;TOPICAL | 207071 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-829 | N | 50419-829-01 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, FOAM;TOPICAL | Strength | 15% | ||||
| Approval Date: | Jul 29, 2015 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jul 29, 2018 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | ➤ Sign Up | Patent Expiration: | Sep 8, 2019 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ➤ Sign Up | Patent Expiration: | Sep 18, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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