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Details for New Drug Application (NDA): 210130
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NDA 210130 describes EVEROLIMUS, which is a drug marketed by Mylan, Hikma, Par Pharm, and Teva Pharms Usa, and is included in six NDAs. It is available from four 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. Five 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. Five suppliers are listed for this compound. Additional details are available on the everolimus profile page.
Summary for 210130
| Tradename: | EVEROLIMUS |
| Applicant: | Mylan |
| Ingredient: | everolimus |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 210130
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 2MG | ||||
| Approval Date: | Apr 19, 2019 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 3MG | ||||
| Approval Date: | Apr 19, 2019 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 5MG | ||||
| Approval Date: | Apr 19, 2019 | TE: | RLD: | No | |||||
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