Orange Book product · Generic (ANDA)
PROMETH VC W/ CODEINE
CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
At a glance
Oct 31, 1984
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 31, 1984
42 yr 3 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
Not listed
Application
ANDA 088764
Product number
001
Marketing status
DISCN
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
- 2015PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATEGeneric (ANDA)
ANDA 200963 · AMNEAL 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
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.
