Orange Book product · Generic (ANDA)
PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
At a glance
Aug 25, 2009
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 25, 2009
17 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
Strength
5MG/5ML;6.25MG/5ML
Dosage form
SYRUP
Route
ORAL
TE code
AA
Application
ANDA 040902
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
- 1984PHENERGAN VCBrand (NDA)
NDA 008604 · ANI PHARMS
- 2014PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 040675 · HIKMA
- 2006PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 040654 · PAI HOLDINGS
- 1987PHERAZINE VCGeneric (ANDA)
ANDA 088868 · HALSEY
- 1985PROMETHAZINE VC PLAINGeneric (ANDA)
ANDA 088815 · CENCI
- 1985PROMETHAZINE VC PLAINGeneric (ANDA)
ANDA 088897 · XTTRIUM LABS INC
- 1984PROMETH VC PLAINGeneric (ANDA)
ANDA 088761 · G AND W LABS INC
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.
