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.
Reference-listed drug:SOMA COMPOUND W/ CODEINE · NDA 012366
1
Brand (NDA)
3
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SOMA COMPOUND W/ CODEINE | MEDA PHARMS | NDA 012366 | — | Jul 11, 1983 |
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE | INGENUS PHARMS NJ | ANDA 040860 | — | Jan 07, 2010 | |
| CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE | OXFORD PHARMS | ANDA 040283 | — | Dec 29, 1998 | |
| CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE | SANDOZ | ANDA 040118 | — | Apr 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.

