Details for New Drug Application (NDA): 218863
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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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