Details for New Drug Application (NDA): 217216
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NDA 217216 describes EVEROLIMUS, which is a drug marketed by Amneal, Biocon Pharma, Mylan, Natco, Alkem Labs Ltd, Breckenridge, Hikma, Novugen, Ph Health, and Teva Pharms Usa, and is included in sixteen NDAs. It is available from ten 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. Eleven 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. Eleven suppliers are listed for this compound. Additional details are available on the everolimus profile page.
Summary for 217216
| Tradename: | EVEROLIMUS |
| Applicant: | Biocon Pharma |
| Ingredient: | everolimus |
| Patents: | 0 |
Pharmacology for NDA: 217216
| 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 217216
Suppliers and Packaging for NDA: 217216
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EVEROLIMUS | everolimus | TABLET, FOR SUSPENSION;ORAL | 217216 | ANDA | Biocon Pharma Inc. | 70377-090 | 70377-090-11 | 28 TABLET, FOR SUSPENSION in 1 BOTTLE (70377-090-11) |
| EVEROLIMUS | everolimus | TABLET, FOR SUSPENSION;ORAL | 217216 | ANDA | Biocon Pharma Inc. | 70377-090 | 70377-090-23 | 4 BLISTER PACK in 1 CARTON (70377-090-23) / 7 TABLET, FOR SUSPENSION in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 2MG | ||||
| Approval Date: | Jan 9, 2026 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 3MG | ||||
| Approval Date: | Jan 9, 2026 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 5MG | ||||
| Approval Date: | Jan 9, 2026 | TE: | AB | RLD: | No | ||||
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