FDA Orange Book · active-ingredient family
Aspirin; caffeine; orphenadrine citrate
Aspirin; caffeine; orphenadrine citrate is approved as 1 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:NORGESIC · NDA 013416
1
Brand (NDA)
4
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NORGESICRLD×2 | BAUSCH | NDA 013416 | — | Oct 27, 1982 |
Generic (ANDA) products (4)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE×2 | STEVENS J | ANDA 074988 | — | Apr 30, 1999 | |
| ORPHENGESIC×2 | GALT PHARMS | ANDA 075141 | — | May 29, 1998 | |
| ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE×2 | SANDOZ | ANDA 074654 | — | Dec 31, 1996 | |
| INVAGESIC×2 | CHARTWELL RX | ANDA 074817 | — | Nov 27, 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; caffeine; orphenadrine citrate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

