FDA Orange Book · active-ingredient family
Acetaminophen; caffeine; dihydrocodeine bitartrate
Acetaminophen; caffeine; dihydrocodeine bitartrate is approved in 9 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
0
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE | PHARMOBEDIENT | ANDA 204209 | — | Sep 30, 2016 | |
| TREZIX | KEY THERAP | ANDA 204785 | — | Nov 26, 2014 | |
| ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE | WRASER PHARMS LLC | ANDA 040688 | — | Apr 03, 2007 | |
| ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE | BOCA PHARMA LLC | ANDA 040701 | — | Apr 03, 2007 | |
| ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE | WEST-WARD PHARM CORP | ANDA 040637 | — | Sep 22, 2006 | |
| ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE | MIKART | ANDA 040316 | — | Apr 28, 1999 | |
| ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE | MIKART | ANDA 040109 | — | Aug 26, 1997 | |
| SYNALGOS-DC-A | LEITNER PHARMS | ANDA 089166 | — | May 14, 1986 | |
| DHC PLUS | PHARM RES ASSOC | ANDA 088584 | — | Mar 04, 1986 |
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; caffeine; dihydrocodeine bitartrate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
