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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021083

RAPAMUNE (SIROLIMUS)
1MG/ML
Marketing Status: Prescription
Active Ingredient: SIROLIMUS
Proprietary Name: RAPAMUNE
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 1MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AA
Application Number: N021083
Product Number: 001
Approval Date: Sep 15, 1999
Applicant Holder Full Name: PF PRISM CV
Marketing Status:  Prescription
Patent and Exclusivity Information
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