Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 205003

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PRESTALIA (AMLODIPINE BESYLATE; PERINDOPRIL ARGININE)
EQ 2.5MG BASE;3.5MG
Marketing Status: Discontinued

Active Ingredient: AMLODIPINE BESYLATE; PERINDOPRIL ARGININE
Proprietary Name: PRESTALIA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 2.5MG BASE;3.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N205003
Product Number: 001
Approval Date: Jan 21, 2015
Applicant Holder Full Name: ADHERA THERAPEUTICS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

PRESTALIA (AMLODIPINE BESYLATE; PERINDOPRIL ARGININE)
EQ 5MG BASE;7MG
Marketing Status: Discontinued

Active Ingredient: AMLODIPINE BESYLATE; PERINDOPRIL ARGININE
Proprietary Name: PRESTALIA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE;7MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N205003
Product Number: 002
Approval Date: Jan 21, 2015
Applicant Holder Full Name: ADHERA THERAPEUTICS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

PRESTALIA (AMLODIPINE BESYLATE; PERINDOPRIL ARGININE)
EQ 10MG BASE;14MG
Marketing Status: Discontinued

Active Ingredient: AMLODIPINE BESYLATE; PERINDOPRIL ARGININE
Proprietary Name: PRESTALIA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE;14MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N205003
Product Number: 003
Approval Date: Jan 21, 2015
Applicant Holder Full Name: ADHERA THERAPEUTICS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information