Orange Book product · Generic (ANDA)
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN
Generic (ANDA)ANDA 090397OTC BIONPHARMA
At a glance
Nov 22, 2010
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 22, 2010
15 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN
Strength
25MG;EQ 200MG FREE ACID AND POTASSIUM SALT
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
ANDA 090397
Product number
001
Marketing status
OTC
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN
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.
