Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021110

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RAPAMUNE (SIROLIMUS)
0.5MG Marketing Status: Prescription

Active Ingredient: SIROLIMUS
Proprietary Name: RAPAMUNE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021110
Product Number: 004
Approval Date: Jan 25, 2010
Applicant Holder Full Name: PF PRISM CV
Marketing Status:  Prescription
Patent and Exclusivity Information

RAPAMUNE (SIROLIMUS)
1MG Marketing Status: Prescription

Active Ingredient: SIROLIMUS
Proprietary Name: RAPAMUNE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021110
Product Number: 001
Approval Date: Aug 25, 2000
Applicant Holder Full Name: PF PRISM CV
Marketing Status:  Prescription
Patent and Exclusivity Information

RAPAMUNE (SIROLIMUS)
2MG Marketing Status: Prescription

Active Ingredient: SIROLIMUS
Proprietary Name: RAPAMUNE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021110
Product Number: 002
Approval Date: Aug 22, 2002
Applicant Holder Full Name: PF PRISM CV
Marketing Status:  Prescription
Patent and Exclusivity Information

RAPAMUNE (SIROLIMUS)
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Marketing Status: Discontinued

Active Ingredient: SIROLIMUS
Proprietary Name: RAPAMUNE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021110
Product Number: 003
Approval Date: Feb 23, 2004
Applicant Holder Full Name: PF PRISM CV
Marketing Status:  Discontinued
Patent and Exclusivity Information

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