Details for New Drug Application (NDA): 203985
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NDA 203985 describes AFINITOR DISPERZ, which is a drug marketed by Novartis Pharm and is included in one NDA. It is available from one supplier. Additional details are available on the AFINITOR DISPERZ profile page.
The generic ingredient in AFINITOR DISPERZ is everolimus. There are twelve drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the everolimus profile page.
The generic ingredient in AFINITOR DISPERZ is everolimus. There are twelve drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the everolimus profile page.
Summary for 203985
| Tradename: | AFINITOR DISPERZ |
| Applicant: | Novartis Pharm |
| Ingredient: | everolimus |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 203985
| 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 203985
Suppliers and Packaging for NDA: 203985
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AFINITOR DISPERZ | everolimus | TABLET, FOR SUSPENSION;ORAL | 203985 | NDA | Novartis Pharmaceuticals Corporation | 0078-0626 | 0078-0626-51 | 28 BLISTER PACK in 1 CARTON (0078-0626-51) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (0078-0626-61) |
| AFINITOR DISPERZ | everolimus | TABLET, FOR SUSPENSION;ORAL | 203985 | NDA | Novartis Pharmaceuticals Corporation | 0078-0627 | 0078-0627-51 | 28 BLISTER PACK in 1 CARTON (0078-0627-51) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (0078-0627-61) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 2MG | ||||
| Approval Date: | Aug 29, 2012 | TE: | AB | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Apr 10, 2025 | ||||||||
| Regulatory Exclusivity Use: | FOR THE ADJUNCTIVE TREATMENT OF ADULT AND PEDIATRIC PATIENTS AGED 2 YEARS AND OLDER WITH TUBEROUS SCLEROSIS COMPLEX (TSC)-ASSOCIATED PARTIAL-ONSET SEIZURES | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 3MG | ||||
| Approval Date: | Aug 29, 2012 | TE: | AB | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Apr 10, 2025 | ||||||||
| Regulatory Exclusivity Use: | FOR THE ADJUNCTIVE TREATMENT OF ADULT AND PEDIATRIC PATIENTS AGED 2 YEARS AND OLDER WITH TUBEROUS SCLEROSIS COMPLEX (TSC)-ASSOCIATED PARTIAL-ONSET SEIZURES | ||||||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 5MG | ||||
| Approval Date: | Aug 29, 2012 | TE: | AB | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Apr 10, 2025 | ||||||||
| Regulatory Exclusivity Use: | FOR THE ADJUNCTIVE TREATMENT OF ADULT AND PEDIATRIC PATIENTS AGED 2 YEARS AND OLDER WITH TUBEROUS SCLEROSIS COMPLEX (TSC)-ASSOCIATED PARTIAL-ONSET SEIZURES | ||||||||
Expired US Patents for NDA 203985
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