Orange Book product · Generic (ANDA)
PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE
CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
At a glance
Dec 07, 2006
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 07, 2006
19 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
Strength
10MG/5ML;5MG/5ML;6.25MG/5ML
Dosage form
SYRUP
Route
ORAL
TE code
AA
Application
ANDA 040660
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
- 1984PHENERGAN VC W/ CODEINEBrand (NDA)
NDA 008306 · ANI PHARMS
- 2015PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATEGeneric (ANDA)
ANDA 200963 · AMNEAL PHARMS
- 2014PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATEGeneric (ANDA)
ANDA 040674 · HIKMA
- 1987PHERAZINE VC W/ CODEINEGeneric (ANDA)
ANDA 088870 · HALSEY
- 1985PROMETHAZINE VC W/ CODEINEGeneric (ANDA)
ANDA 088816 · CENCI
- 1985PROMETHAZINE VC W/ CODEINEGeneric (ANDA)
ANDA 088896 · WOCKHARDT
- 1984PROMETH VC W/ CODEINEGeneric (ANDA)
ANDA 088764 · CHARTWELL RX
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.
