Orange Book product · Brand (NDA)
PHENERGAN VC
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
PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
Strength
5MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 008604
Product number
003
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.
- 2014PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 040675 · HIKMA
- 2009PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDEGeneric (ANDA)
ANDA 040902 · AMNEAL PHARMS
- 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.
