Assyro AI

FDA Orange Book · active-ingredient family

Aspirin; carisoprodol; codeine phosphate

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

1

Brand (NDA)

3

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
SOMA COMPOUND W/ CODEINEMEDA PHARMSNDA 012366Jul 11, 1983

Generic (ANDA) products (3)

ProductApplicantApplicationTEApproved
CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATEINGENUS PHARMS NJANDA 040860Jan 07, 2010
CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATEOXFORD PHARMSANDA 040283Dec 29, 1998
CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATESANDOZANDA 040118Apr 16, 1996

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; carisoprodol; codeine phosphate — 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.