FDA Orange Book · active-ingredient family
Codeine phosphate; promethazine hydrochloride
Codeine phosphate; promethazine hydrochloride is approved as 1 brand and 11 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PHENERGAN W/ CODEINE · NDA 008306
1
Brand (NDA)
11
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · syrup
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PHENERGAN W/ CODEINERLD | ANI PHARMS | NDA 008306 | — | Apr 02, 1984 |
Generic (ANDA) products (11)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE | QUAGEN | ANDA 214238 | AA | Oct 08, 2020 | |
| PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE | AMNEAL PHARMS | ANDA 200894 | AA | Apr 24, 2013 | |
| PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE | COSETTE PHARMS NC | ANDA 200386 | AA | Jun 29, 2012 | |
| PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE | CHARTWELL RX | ANDA 090180 | AA | Mar 17, 2010 | |
| PROMETHAZINE WITH CODEINE | PHARM ASSOC | ANDA 040650 | — | Jan 31, 2006 | |
| PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE | HIKMA | ANDA 040151 | — | Aug 26, 1997 | |
| PHERAZINE W/ CODEINE | HALSEY | ANDA 088739 | — | Dec 23, 1988 | |
| PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE | PHARM ASSOC | ANDA 089647 | — | Dec 22, 1988 | |
| PROMETHAZINE W/ CODEINE | CENCI | ANDA 088814 | — | Nov 22, 1985 | |
| PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE | PHARMOBEDIENT | ANDA 088875 | AA | Dec 17, 1984 | |
| PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATERLD | ACTAVIS MID ATLANTIC | ANDA 088763 | — | 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.
Codeine phosphate; promethazine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
