Assyro AI

FDA Orange Book · active-ingredient family

Amlodipine besylate; celecoxib

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

Reference-listed drug:CONSENSI · NDA 210045

1

Brand (NDA)

0

Generics (ANDA)

1

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
CONSENSIRLD×3PURPLE BIOTECHNDA 210045May 31, 2018

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10350171Jun 14, 2038in 12 yr 2 mo
Product

Amlodipine besylate; celecoxib — frequently asked questions

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

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.