Orange Book product · Generic (ANDA)
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE
At a glance
Oct 08, 2020
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 08, 2020
5 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE
Strength
10MG/5ML;6.25MG/5ML
Dosage form
SYRUP
Route
ORAL
TE code
AA
Application
ANDA 214238
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; PROMETHAZINE HYDROCHLORIDE
- 1984PHENERGAN W/ CODEINEBrand (NDA)
NDA 008306 · ANI PHARMS
- 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.
