Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022026

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AMLODIPINE BESYLATE (AMLODIPINE BESYLATE)
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: No
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)
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: No
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)
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: No
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

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