FDA Orange Book · active-ingredient family
Aspirin; caffeine; dihydrocodeine bitartrate
Aspirin; caffeine; dihydrocodeine bitartrate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:SYNALGOS-DC · NDA 011483
1
Brand (NDA)
0
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SYNALGOS-DCRLD | SUN PHARM INDUSTRIES | NDA 011483 | — | Sep 06, 1983 |
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; caffeine; dihydrocodeine bitartrate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

