Details for New Drug Application (NDA): 021083
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NDA 021083 describes RAPAMUNE, which is a drug marketed by Pf Prism Cv and is included in two NDAs. It is available from one supplier. 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 021083
| Tradename: | RAPAMUNE |
| Applicant: | Pf Prism Cv |
| Ingredient: | sirolimus |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 021083
Suppliers and Packaging for NDA: 021083
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RAPAMUNE | sirolimus | SOLUTION;ORAL | 021083 | NDA AUTHORIZED GENERIC | Mylan Pharmaceuticals Inc. | 59762-1205 | 59762-1205-6 | 1 CARTON in 1 KIT (59762-1205-6) / 1 BOTTLE, GLASS in 1 CARTON (59762-1205-4) / 60 mL in 1 BOTTLE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 1MG/ML | ||||
| Approval Date: | Sep 15, 1999 | TE: | AA | RLD: | Yes | ||||
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