Details for New Drug Application (NDA): 205432
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NDA 205432 describes EVEROLIMUS, which is a drug marketed by Mylan, Alkem Labs Ltd, Biocon Pharma, Breckenridge, Endo Operations, Hikma, and Teva Pharms Usa, and is included in eleven 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 205432
| Tradename: | EVEROLIMUS |
| Applicant: | Breckenridge |
| Ingredient: | everolimus |
| Patents: | 0 |
Pharmacology for NDA: 205432
| 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 205432
Suppliers and Packaging for NDA: 205432
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EVEROLIMUS | everolimus | TABLET;ORAL | 205432 | ANDA | Breckenridge Pharmaceutical, Inc. | 51991-379 | 51991-379-06 | 60 TABLET in 1 BOTTLE (51991-379-06) |
| EVEROLIMUS | everolimus | TABLET;ORAL | 205432 | ANDA | Breckenridge Pharmaceutical, Inc. | 51991-379 | 51991-379-60 | 60 BLISTER PACK in 1 CARTON (51991-379-60) / 10 TABLET in 1 BLISTER PACK (51991-379-99) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.25MG | ||||
| Approval Date: | May 20, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
| Approval Date: | May 20, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.75MG | ||||
| Approval Date: | May 20, 2021 | TE: | AB | RLD: | No | ||||
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