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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 216018

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ASPRUZYO SPRINKLE (RANOLAZINE)
500MG
Marketing Status: Prescription
Active Ingredient: RANOLAZINE
Proprietary Name: ASPRUZYO SPRINKLE
Dosage Form; Route of Administration: GRANULES, EXTENDED RELEASE; ORAL
Strength: 500MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N216018
Product Number: 001
Approval Date: Feb 28, 2022
Applicant Holder Full Name: SUN PHARMA INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
ASPRUZYO SPRINKLE (RANOLAZINE)
1GM
Marketing Status: Prescription
Active Ingredient: RANOLAZINE
Proprietary Name: ASPRUZYO SPRINKLE
Dosage Form; Route of Administration: GRANULES, EXTENDED RELEASE; ORAL
Strength: 1GM
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216018
Product Number: 002
Approval Date: Feb 28, 2022
Applicant Holder Full Name: SUN PHARMA INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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