Orange Book product · Brand (NDA)
PHENERGAN W/ CODEINE
CODEINE PHOSPHATE; 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; PROMETHAZINE HYDROCHLORIDE
Strength
10MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
004
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.
- 2020PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATEGeneric (ANDA)
ANDA 214238 · QUAGEN
- 2013PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATEGeneric (ANDA)
ANDA 200894 · AMNEAL PHARMS
- 2012PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATEGeneric (ANDA)
ANDA 200386 · COSETTE PHARMS NC
- 2010PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATEGeneric (ANDA)
ANDA 090180 · CHARTWELL RX
- 2006PROMETHAZINE WITH CODEINEGeneric (ANDA)
ANDA 040650 · PHARM ASSOC
- 1997PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATEGeneric (ANDA)
ANDA 040151 · HIKMA
- 1988PHERAZINE W/ CODEINEGeneric (ANDA)
ANDA 088739 · HALSEY
- 1988PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATEGeneric (ANDA)
ANDA 089647 · PHARM ASSOC
- 1985PROMETHAZINE W/ CODEINEGeneric (ANDA)
ANDA 088814 · CENCI
- 1984PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATEGeneric (ANDA)
ANDA 088875 · PHARMOBEDIENT
- 1984PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATEGeneric (ANDA)
ANDA 088763 · ACTAVIS MID ATLANTIC
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.
