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FDA Orange Book · active-ingredient family

Celecoxib; tramadol hydrochloride

Celecoxib; tramadol hydrochloride is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:SEGLENTIS · NDA 213426

1

Brand (NDA)

0

Generics (ANDA)

7

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
SEGLENTISRLDKOWA PHARMSNDA 213426Oct 15, 2021

Listed patents (7)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10238668Apr 19, 2030in 3 yr 11 mo
SubstanceProductU-3244
10548909Apr 19, 2030in 3 yr 11 mo
U-3244
11478488Apr 19, 2030in 3 yr 11 mo
U-3244
9012440Apr 19, 2030in 3 yr 11 mo
SubstanceProduct
10245276Apr 19, 2030in 3 yr 11 mo
SubstanceProduct
8598152Apr 19, 2030in 3 yr 11 mo
SubstanceProduct
8846744Jun 03, 2031in 5 yr
Product

Celecoxib; tramadol hydrochloride — 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.