Orange Book product · Brand (NDA)
AMBENYL
BROMODIPHENHYDRAMINE HYDROCHLORIDE; CODEINE PHOSPHATE
Brand (NDA)NDA 009319DISCN FOREST LABS
At a glance
Jan 10, 1984
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 10, 1984
43 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
BROMODIPHENHYDRAMINE HYDROCHLORIDE; CODEINE PHOSPHATE
Strength
12.5MG/5ML;10MG/5ML
Dosage form
SYRUP
Route
ORAL
TE code
Not listed
Application
NDA 009319
Product number
006
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
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.
