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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 211829

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RANOLAZINE (RANOLAZINE)
500MG
Marketing Status: Prescription
Active Ingredient: RANOLAZINE
Proprietary Name: RANOLAZINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 500MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211829
Product Number: 001
Approval Date: Jun 4, 2019
Applicant Holder Full Name: SCIEGEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
RANOLAZINE (RANOLAZINE)
1GM
Marketing Status: Prescription
Active Ingredient: RANOLAZINE
Proprietary Name: RANOLAZINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 1GM
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211829
Product Number: 002
Approval Date: Jun 4, 2019
Applicant Holder Full Name: SCIEGEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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