FDA Orange Book · active-ingredient family
Acetaminophen; aspirin; codeine phosphate
Acetaminophen; aspirin; codeine phosphate is approved in 6 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
0
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE | MIKART | ANDA 081095 | — | Oct 26, 1990 | |
| ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE | MIKART | ANDA 081096 | — | Oct 26, 1990 | |
| ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE | MIKART | ANDA 081097 | — | Oct 26, 1990 | |
| CODEINE, ASPIRIN, APAP FORMULA NO. 2RLD | SCHERER LABS | ANDA 085640 | — | Approved Prior to Jan 1, 1982 | |
| CODEINE, ASPIRIN, APAP FORMULA NO. 3RLD | SCHERER LABS | ANDA 085639 | — | Approved Prior to Jan 1, 1982 | |
| CODEINE, ASPIRIN, APAP FORMULA NO. 4 | SCHERER LABS | ANDA 085638 | — | Approved Prior to Jan 1, 1982 |
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.
Acetaminophen; aspirin; codeine phosphate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
