FDA Orange Book · active-ingredient family
Dextromethorphan hydrobromide; promethazine hydrochloride
Dextromethorphan hydrobromide; promethazine hydrochloride is approved as 1 brand and 8 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE · NDA 011265
1
Brand (NDA)
8
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · syrup
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDERLD | ANI PHARMS | NDA 011265 | AA | Apr 02, 1984 |
Generic (ANDA) products (8)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | HETERO LABS LTD III | ANDA 218264 | AA | Mar 12, 2026 | |
| PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | COSETTE PHARMS NC | ANDA 091687 | AA | Jun 28, 2012 | |
| PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | AMNEAL PHARMS | ANDA 090575 | AA | Feb 08, 2011 | |
| PROMETHAZINE DM | PAI HOLDINGS | ANDA 040649 | AA | Feb 14, 2006 | |
| PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | HIKMA | ANDA 040027 | — | Jul 31, 1996 | |
| PHERAZINE DM | HALSEY | ANDA 088913 | — | Mar 02, 1987 | |
| PROMETHAZINE W/ DEXTROMETHORPHAN | PHARMOBEDIENT | ANDA 088864 | AA | Jan 04, 1985 | |
| PROMETH W/ DEXTROMETHORPHAN | G AND W LABS INC | ANDA 088762 | — | Oct 31, 1984 |
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.
Dextromethorphan hydrobromide; promethazine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
