Details for New Drug Application (NDA): 219955
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NDA 219955 describes EVEROLIMUS, which is a drug marketed by Amneal, Biocon Pharma, Mylan, Natco, Alkem Labs Ltd, Breckenridge, Eugia Pharma, Hikma, Novugen, Ph Health, and Teva Pharms Usa, and is included in seventeen NDAs. It is available from twelve 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. Thirteen 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. Thirteen suppliers are listed for this compound. Additional details are available on the everolimus profile page.
Summary for 219955
| Tradename: | EVEROLIMUS |
| Applicant: | Novugen |
| Ingredient: | everolimus |
| Patents: | 0 |
Pharmacology for NDA: 219955
| 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 219955
Suppliers and Packaging for NDA: 219955
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EVEROLIMUS | everolimus | TABLET;ORAL | 219955 | ANDA | Novugen Pharma (USA) LLC. | 82293-030 | 82293-030-10 | 28 TABLET in 1 BOTTLE (82293-030-10) |
| EVEROLIMUS | everolimus | TABLET;ORAL | 219955 | ANDA | Novugen Pharma (USA) LLC. | 82293-030 | 82293-030-21 | 4 BLISTER PACK in 1 CARTON (82293-030-21) / 7 TABLET in 1 BLISTER PACK (82293-030-20) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
| Approval Date: | Oct 30, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Oct 30, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 7.5MG | ||||
| Approval Date: | Oct 30, 2025 | TE: | AB | RLD: | No | ||||
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