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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 210464

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SEVELAMER CARBONATE (SEVELAMER CARBONATE)
800MG/PACKET
Marketing Status: Prescription
Active Ingredient: SEVELAMER CARBONATE
Proprietary Name: SEVELAMER CARBONATE
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 800MG/PACKET
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A210464
Product Number: 001
Approval Date: Oct 25, 2018
Applicant Holder Full Name: DR REDDYS LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
SEVELAMER CARBONATE (SEVELAMER CARBONATE)
2.4GM/PACKET
Marketing Status: Prescription
Active Ingredient: SEVELAMER CARBONATE
Proprietary Name: SEVELAMER CARBONATE
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 2.4GM/PACKET
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A210464
Product Number: 002
Approval Date: Oct 25, 2018
Applicant Holder Full Name: DR REDDYS LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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