Details for New Drug Application (NDA): 021110
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NDA 021110 describes RAPAMUNE, which is a drug marketed by Pf Prism Cv and is included in two NDAs. It is available from two suppliers. Additional details are available on the RAPAMUNE profile page.
The generic ingredient in RAPAMUNE is sirolimus. There are twenty-one drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the sirolimus profile page.
The generic ingredient in RAPAMUNE is sirolimus. There are twenty-one drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the sirolimus profile page.
Summary for 021110
| Tradename: | RAPAMUNE |
| Applicant: | Pf Prism Cv |
| Ingredient: | sirolimus |
| Patents: | 0 |
Pharmacology for NDA: 021110
| Mechanism of Action | Protein Kinase Inhibitors mTOR Inhibitors |
| Physiological Effect | Decreased Immunologic Activity |
Medical Subject Heading (MeSH) Categories for 021110
Suppliers and Packaging for NDA: 021110
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RAPAMUNE | sirolimus | TABLET;ORAL | 021110 | NDA | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-1041 | 0008-1041-05 | 100 TABLET, SUGAR COATED in 1 BOTTLE (0008-1041-05) |
| RAPAMUNE | sirolimus | TABLET;ORAL | 021110 | NDA AUTHORIZED GENERIC | Mylan Pharmaceuticals Inc. | 59762-1001 | 59762-1001-1 | 100 TABLET, SUGAR COATED in 1 BOTTLE (59762-1001-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | Aug 25, 2000 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Aug 22, 2002 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Feb 23, 2004 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 021110
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-003 | Feb 23, 2004 | 5,145,684*PED | ⤷ Get Started Free |
| Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-002 | Aug 22, 2002 | 5,989,591*PED | ⤷ Get Started Free |
| Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-001 | Aug 25, 2000 | 5,145,684*PED | ⤷ Get Started Free |
| Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-003 | Feb 23, 2004 | 5,403,833*PED | ⤷ Get Started Free |
| Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-002 | Aug 22, 2002 | 5,308,847*PED | ⤷ Get Started Free |
| Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-002 | Aug 22, 2002 | 5,100,899*PED | ⤷ Get Started Free |
| Pf Prism Cv | RAPAMUNE | sirolimus | TABLET;ORAL | 021110-004 | Jan 25, 2010 | 5,100,899*PED | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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