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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 205739

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VELTASSA (PATIROMER SORBITEX CALCIUM)
EQ 1GM BASE/PACKET
Marketing Status: Prescription
Active Ingredient: PATIROMER SORBITEX CALCIUM
Proprietary Name: VELTASSA
Dosage Form; Route of Administration: POWDER; ORAL
Strength: EQ 1GM BASE/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N205739
Product Number: 004
Approval Date: Oct 2, 2023
Applicant Holder Full Name: VIFOR PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
VELTASSA (PATIROMER SORBITEX CALCIUM)
EQ 8.4GM BASE/PACKET
Marketing Status: Prescription
Active Ingredient: PATIROMER SORBITEX CALCIUM
Proprietary Name: VELTASSA
Dosage Form; Route of Administration: POWDER; ORAL
Strength: EQ 8.4GM BASE/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N205739
Product Number: 001
Approval Date: Oct 21, 2015
Applicant Holder Full Name: VIFOR PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
VELTASSA (PATIROMER SORBITEX CALCIUM)
EQ 16.8GM BASE/PACKET
Marketing Status: Prescription
Active Ingredient: PATIROMER SORBITEX CALCIUM
Proprietary Name: VELTASSA
Dosage Form; Route of Administration: POWDER; ORAL
Strength: EQ 16.8GM BASE/PACKET
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N205739
Product Number: 002
Approval Date: Oct 21, 2015
Applicant Holder Full Name: VIFOR PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
VELTASSA (PATIROMER SORBITEX CALCIUM)
EQ 25.2GM BASE/PACKET
Marketing Status: Discontinued
Active Ingredient: PATIROMER SORBITEX CALCIUM
Proprietary Name: VELTASSA
Dosage Form; Route of Administration: POWDER; ORAL
Strength: EQ 25.2GM BASE/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N205739
Product Number: 003
Approval Date: Oct 21, 2015
Applicant Holder Full Name: VIFOR PHARMA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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