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RAPAMUNE

NDA · New Drug Application · Sponsor: PF PRISM CV · Approved 1999-09-15

Drug application

FDA Application #

NDA021083

Application type

New Drug Application

Brand name

RAPAMUNE

Generic name

SIROLIMUS

Active ingredients

SIROLIMUS

Dosage form

SOLUTION

Route

ORAL

Marketing status

Prescription

Sponsor

PF PRISM CV

Manufacturer

Mylan Pharmaceuticals Inc.

First approval

1999-09-15

Source

Authoritative

Drugs@FDA application overview

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