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FDA Orange Book · active-ingredient family

Amlodipine besylate; perindopril arginine

Amlodipine besylate; perindopril arginine is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:PRESTALIA · NDA 205003

1

Brand (NDA)

0

Generics (ANDA)

1

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
PRESTALIARLD×3ADHERANDA 205003—Jan 21, 2015

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7846961Oct 05, 2029in 3 yr 4 mo
SubstanceProductU-3

Amlodipine besylate; perindopril arginine — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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