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FDA Orange Book · active-ingredient family

Aspirin; oxycodone hydrochloride

Aspirin; oxycodone hydrochloride is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:PERCODAN · NDA 007337

1

Brand (NDA)

3

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
PERCODANRLDENDO OPERATIONSNDA 007337Aug 05, 2005

Generic (ANDA) products (3)

ProductApplicantApplicationTEApproved
OXYCODONE AND ASPIRINEPIC PHARMA LLCANDA 040910Jul 16, 2020
OXYCODONE AND ASPIRINACTAVIS LABS FL INCANDA 090084Mar 22, 2011
OXYCODONE AND ASPIRINDR REDDYS LABS SAANDA 091670Mar 16, 2011

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Aspirin; oxycodone hydrochloride — 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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