FDA Orange Book · active-ingredient family
Aspirin; caffeine; propoxyphene hydrochloride
Aspirin; caffeine; propoxyphene hydrochloride is approved as 1 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DARVON COMPOUND · NDA 010996
1
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DARVON COMPOUND×2 | XANODYNE PHARM | NDA 010996 | — | Mar 08, 1983 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PROPOXYPHENE COMPOUND-65 | SANDOZ | ANDA 083101 | — | Jun 24, 1985 | |
| PROPOXYPHENE COMPOUND 65 | TEVA | ANDA 089025 | — | Mar 29, 1985 | |
| PROPOXYPHENE COMPOUND 65 | IVAX SUB TEVA PHARMS | ANDA 083077 | — | Dec 07, 1984 | |
| PROPOXYPHENE HYDROCHLORIDE W/ ASPIRIN AND CAFFEINE | WATSON LABS | ANDA 085732 | — | Sep 03, 1984 | |
| PROPOXYPHENE COMPOUND 65RLD | SANDOZ | ANDA 080044 | — | Sep 16, 1983 | |
| COMPOUND 65 | ALRA | ANDA 084553 | — | Aug 17, 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; propoxyphene hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
