FDA Orange Book · active-ingredient family
Acetaminophen; aspirin; caffeine
Acetaminophen; aspirin; caffeine 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:EXCEDRIN (MIGRAINE RELIEF) · NDA 020802
1
Brand (NDA)
3
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EXCEDRIN (MIGRAINE RELIEF)RLD | HALEON US HOLDINGS | NDA 020802 | — | Jan 14, 1998 |
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ACETAMINOPHEN, ASPIRIN AND CAFFEINE | AUROBINDO PHARMA LTD | ANDA 211695 | — | Feb 02, 2022 | |
| ACETAMINOPHEN, ASPIRIN AND CAFFEINE | GRANULES | ANDA 214039 | — | Feb 23, 2021 | |
| ACETAMINOPHEN, ASPIRIN AND CAFFEINE | PERRIGO | ANDA 075794 | — | Nov 26, 2001 |
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; caffeine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
