Details for New Drug Application (NDA): 214138
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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 214138
Tradename: | EVEROLIMUS |
Applicant: | Alkem Labs Ltd |
Ingredient: | everolimus |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 214138
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 214138
Suppliers and Packaging for NDA: 214138
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
EVEROLIMUS | everolimus | TABLET;ORAL | 214138 | ANDA | Ascend Laboratories, LLC | 67877-718 | 67877-718-31 | 6 BLISTER PACK in 1 CARTON (67877-718-31) / 10 TABLET in 1 BLISTER PACK (67877-718-33) |
EVEROLIMUS | everolimus | TABLET;ORAL | 214138 | ANDA | Ascend Laboratories, LLC | 67877-719 | 67877-719-31 | 6 BLISTER PACK in 1 CARTON (67877-719-31) / 10 TABLET in 1 BLISTER PACK (67877-719-33) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.25MG | ||||
Approval Date: | Nov 26, 2021 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
Approval Date: | Nov 26, 2021 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.75MG | ||||
Approval Date: | Nov 26, 2021 | TE: | AB | RLD: | No |
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