Orange Book product · Brand (NDA)
PHENERGAN VC W/ CODEINE
CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
At a glance
Apr 02, 1984
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 02, 1984
42 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
Strength
10MG/5ML;5MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SYRUP
Route
ORAL
TE code
Not listed
Application
NDA 008306
Product number
005
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 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
- 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.
