Product Details for NDA 022026
AMLODIPINE BESYLATE (AMLODIPINE BESYLATE)
EQ 2.5MG BASE
Marketing Status: Discontinued
EQ 5MG BASE
Marketing Status: Discontinued
EQ 10MG BASE
Marketing Status: Discontinued
EQ 2.5MG BASE
Marketing Status: Discontinued
Active Ingredient: AMLODIPINE BESYLATE
Proprietary Name: AMLODIPINE BESYLATE
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: EQ 2.5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N022026
Product Number: 001
Approval Date: Sep 27, 2007
Applicant Holder Full Name: SYNTHON PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
AMLODIPINE BESYLATE (AMLODIPINE BESYLATE)
Proprietary Name: AMLODIPINE BESYLATE
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: EQ 2.5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N022026
Product Number: 001
Approval Date: Sep 27, 2007
Applicant Holder Full Name: SYNTHON PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 5MG BASE
Marketing Status: Discontinued
Active Ingredient: AMLODIPINE BESYLATE
Proprietary Name: AMLODIPINE BESYLATE
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: EQ 5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N022026
Product Number: 002
Approval Date: Sep 27, 2007
Applicant Holder Full Name: SYNTHON PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
AMLODIPINE BESYLATE (AMLODIPINE BESYLATE)
Proprietary Name: AMLODIPINE BESYLATE
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: EQ 5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N022026
Product Number: 002
Approval Date: Sep 27, 2007
Applicant Holder Full Name: SYNTHON PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 10MG BASE
Marketing Status: Discontinued
Active Ingredient: AMLODIPINE BESYLATE
Proprietary Name: AMLODIPINE BESYLATE
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N022026
Product Number: 003
Approval Date: Sep 27, 2007
Applicant Holder Full Name: SYNTHON PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: AMLODIPINE BESYLATE
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N022026
Product Number: 003
Approval Date: Sep 27, 2007
Applicant Holder Full Name: SYNTHON PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information