Orange Book product · Generic (ANDA)
PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE
CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
At a glance
Aug 26, 2015
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 26, 2015
11 yr 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 200963
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
- 1984PHENERGAN VC W/ CODEINEBrand (NDA)
NDA 008306 · ANI PHARMS
- 2014PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATEGeneric (ANDA)
ANDA 040674 · HIKMA
- 2006PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATEGeneric (ANDA)
ANDA 040660 · PAI HOLDINGS
- 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.
