Details for New Drug Application (NDA): 210050
✉ Email this page to a colleague
The generic ingredient in EVEROLIMUS is everolimus. There are twelve drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the everolimus profile page.
Summary for 210050
Tradename: | EVEROLIMUS |
Applicant: | Teva Pharms Usa |
Ingredient: | everolimus |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 210050
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 210050
Suppliers and Packaging for NDA: 210050
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
EVEROLIMUS | everolimus | TABLET;ORAL | 210050 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-7766 | 0093-7766-24 | 28 BLISTER PACK in 1 CARTON (0093-7766-24) / 1 TABLET in 1 BLISTER PACK (0093-7766-19) |
EVEROLIMUS | everolimus | TABLET;ORAL | 210050 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-7767 | 0093-7767-24 | 28 BLISTER PACK in 1 CARTON (0093-7767-24) / 1 TABLET in 1 BLISTER PACK (0093-7767-19) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
Approval Date: | Dec 9, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Dec 9, 2019 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 7.5MG | ||||
Approval Date: | Dec 9, 2019 | TE: | AB | RLD: | No |
Complete Access Available with Subscription