Orange Book product · Generic (ANDA)
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
CODEINE PHOSPHATE; 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; 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10MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
ANDA 088763
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE
- 1984PHENERGAN W/ CODEINEBrand (NDA)
NDA 008306 · ANI PHARMS
- 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
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.
