Details for New Drug Application (NDA): 218863
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NDA 218863 describes EVEROLIMUS, which is a drug marketed by Amneal, Mylan, Natco, Alkem Labs Ltd, Biocon Pharma, Breckenridge, Hikma, Novugen, Ph Health, and Teva Pharms Usa, and is included in fifteen NDAs. It is available from eleven suppliers. Additional details are available on the EVEROLIMUS profile page.
The generic ingredient in EVEROLIMUS is everolimus. There are twelve drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the everolimus profile page.
The generic ingredient in EVEROLIMUS is everolimus. There are twelve drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the everolimus profile page.
Summary for 218863
| Tradename: | EVEROLIMUS |
| Applicant: | Amneal |
| Ingredient: | everolimus |
| Patents: | 0 |
Pharmacology for NDA: 218863
| 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 218863
Suppliers and Packaging for NDA: 218863
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EVEROLIMUS | everolimus | TABLET, FOR SUSPENSION;ORAL | 218863 | ANDA | Amneal Pharmaceuticals NY LLC | 60219-2279 | 60219-2279-2 | 4 BLISTER PACK in 1 CARTON (60219-2279-2) / 7 TABLET, FOR SUSPENSION in 1 BLISTER PACK (60219-2279-1) |
| EVEROLIMUS | everolimus | TABLET, FOR SUSPENSION;ORAL | 218863 | ANDA | Amneal Pharmaceuticals NY LLC | 60219-2280 | 60219-2280-2 | 4 BLISTER PACK in 1 CARTON (60219-2280-2) / 7 TABLET, FOR SUSPENSION in 1 BLISTER PACK (60219-2280-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 2MG | ||||
| Approval Date: | Jan 10, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 3MG | ||||
| Approval Date: | Jan 10, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 5MG | ||||
| Approval Date: | Jan 10, 2025 | TE: | AB | RLD: | No | ||||
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