FDA Orange Book · active-ingredient family
Codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride
Codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride is approved as 1 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PHENERGAN VC W/ CODEINE · NDA 008306
1
Brand (NDA)
7
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · syrup
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PHENERGAN VC W/ CODEINERLD | ANI PHARMS | NDA 008306 | — | Apr 02, 1984 |
Generic (ANDA) products (7)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE | AMNEAL PHARMS | ANDA 200963 | AA | Aug 26, 2015 | |
| PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE | HIKMA | ANDA 040674 | — | Dec 23, 2014 | |
| PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE | PAI HOLDINGS | ANDA 040660 | AA | Dec 07, 2006 | |
| PHERAZINE VC W/ CODEINE | HALSEY | ANDA 088870 | — | Mar 02, 1987 | |
| PROMETHAZINE VC W/ CODEINE | CENCI | ANDA 088816 | — | Nov 22, 1985 | |
| PROMETHAZINE VC W/ CODEINE | WOCKHARDT | ANDA 088896 | — | Jan 04, 1985 | |
| PROMETH VC W/ CODEINE | CHARTWELL RX | ANDA 088764 | — | 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; phenylephrine hydrochloride; promethazine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
