Details for New Drug Application (NDA): 213478
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NDA 213478 describes HYFTOR, which is a drug marketed by Nobelpharma and is included in one NDA. It is available from one supplier. Additional details are available on the HYFTOR profile page.
The generic ingredient in HYFTOR is sirolimus. There are twenty-one drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the sirolimus profile page.
The generic ingredient in HYFTOR is sirolimus. There are twenty-one drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the sirolimus profile page.
Summary for 213478
| Tradename: | HYFTOR |
| Applicant: | Nobelpharma |
| Ingredient: | sirolimus |
| Patents: | 0 |
Pharmacology for NDA: 213478
| Mechanism of Action | Protein Kinase Inhibitors mTOR Inhibitors |
| Physiological Effect | Decreased Immunologic Activity |
Medical Subject Heading (MeSH) Categories for 213478
Suppliers and Packaging for NDA: 213478
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HYFTOR | sirolimus | GEL;TOPICAL | 213478 | NDA | Nobelpharma America, LLC | 73683-101 | 73683-101-10 | 1 TUBE in 1 CARTON (73683-101-10) / 10 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | 0.2% | ||||
| Approval Date: | Mar 22, 2022 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 22, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Regulatory Exclusivity Expiration: | Mar 22, 2029 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF FACIAL ANGIOFIBROMA ASSOCIATED WITH TUBEROUS SCLEROSIS IN ADULTS AND PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER | ||||||||
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