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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 201578

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SIROLIMUS (SIROLIMUS)
1MG
Marketing Status: Prescription
Active Ingredient: SIROLIMUS
Proprietary Name: SIROLIMUS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A201578
Product Number: 001
Approval Date: Oct 27, 2014
Applicant Holder Full Name: DR REDDYS LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
SIROLIMUS (SIROLIMUS)
2MG
Marketing Status: Prescription
Active Ingredient: SIROLIMUS
Proprietary Name: SIROLIMUS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A201578
Product Number: 002
Approval Date: Oct 27, 2014
Applicant Holder Full Name: DR REDDYS LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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