Details for New Drug Application (NDA): 207486
NDA 207486 describes EVEROLIMUS, which is a drug marketed by Amneal, Biocon Pharma, Mylan, Natco, Novitium Pharma, Alkem Labs Ltd, Apotex, Breckenridge, Eugia Pharma, Hikma, Neocubes Pharma, Ph Health, Pharmazone, and Teva Pharms Usa, and is included in twenty NDAs. It is available from fourteen suppliers. Additional details are available on the EVEROLIMUS profile page.
The generic ingredient in EVEROLIMUS is everolimus. There is one drug master file entry for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the everolimus profile page.
The generic ingredient in EVEROLIMUS is everolimus. There is one drug master file entry for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the everolimus profile page.
Summary for 207486
| Tradename: | EVEROLIMUS |
| Applicant: | Hikma |
| Ingredient: | everolimus |
| Patents: | 0 |
Pharmacology for NDA: 207486
| Mechanism of Action | Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inhibitors Protein Kinase Inhibitors mTOR Inhibitors |
| Physiological Effect | Decreased Immunologic Activity |
Medical Subject Heading (MeSH) Categories for 207486
Suppliers and Packaging for NDA: 207486
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EVEROLIMUS | everolimus | TABLET;ORAL | 207486 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0480 | 0054-0480-13 | 30 TABLET in 1 BOTTLE (0054-0480-13) |
| EVEROLIMUS | everolimus | TABLET;ORAL | 207486 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0481 | 0054-0481-13 | 30 TABLET in 1 BOTTLE (0054-0481-13) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
| Approval Date: | Jun 8, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Jun 8, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 7.5MG | ||||
| Approval Date: | Jun 8, 2020 | TE: | AB | RLD: | No | ||||
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