Product Details for NDA 021468
FOSRENOL (LANTHANUM CARBONATE)
EQ 500MG BASE
Marketing Status: Prescription
EQ 750MG BASE
Marketing Status: Prescription
EQ 1GM BASE
Marketing Status: Prescription
EQ 250MG BASE
Marketing Status: Discontinued
EQ 500MG BASE
Marketing Status: Prescription
Active Ingredient: LANTHANUM CARBONATE
Proprietary Name: FOSRENOL
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: EQ 500MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021468
Product Number: 002
Approval Date: Oct 26, 2004
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
FOSRENOL (LANTHANUM CARBONATE)
Proprietary Name: FOSRENOL
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: EQ 500MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021468
Product Number: 002
Approval Date: Oct 26, 2004
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 750MG BASE
Marketing Status: Prescription
Active Ingredient: LANTHANUM CARBONATE
Proprietary Name: FOSRENOL
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: EQ 750MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021468
Product Number: 003
Approval Date: Nov 23, 2005
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
FOSRENOL (LANTHANUM CARBONATE)
Proprietary Name: FOSRENOL
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: EQ 750MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021468
Product Number: 003
Approval Date: Nov 23, 2005
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 1GM BASE
Marketing Status: Prescription
Active Ingredient: LANTHANUM CARBONATE
Proprietary Name: FOSRENOL
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: EQ 1GM BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021468
Product Number: 004
Approval Date: Nov 23, 2005
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
FOSRENOL (LANTHANUM CARBONATE)
Proprietary Name: FOSRENOL
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: EQ 1GM BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021468
Product Number: 004
Approval Date: Nov 23, 2005
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 250MG BASE
Marketing Status: Discontinued
Active Ingredient: LANTHANUM CARBONATE
Proprietary Name: FOSRENOL
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: EQ 250MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N021468
Product Number: 001
Approval Date: Oct 26, 2004
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: FOSRENOL
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: EQ 250MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N021468
Product Number: 001
Approval Date: Oct 26, 2004
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information