Orange Book product · Brand (NDA)
BENADRYL
DIPHENHYDRAMINE HYDROCHLORIDE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
DIPHENHYDRAMINE HYDROCHLORIDE
Strength
12.5MG/5ML
Dosage form
ELIXIR
Route
ORAL
TE code
Not listed
Application
NDA 005845
Product number
004
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.
- 1987DIPHENHYDRAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 089488 · SUN PHARM INDUSTRIES
- 1987DIPHENHYDRAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 089489 · SUN PHARM INDUSTRIES
- 1985DIPHENHYDRAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 089101 · PIONEER PHARMS
- 1985DIPHENHYDRAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 088880 · PIONEER PHARMS
- 1985DIPHENHYDRAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 089040 · SUPERPHARM
- 1985DIPHENHYDRAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 089041 · SUPERPHARM
- 1984DIPHENHYDRAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 087914 · HALSEY
- 1983DIBENILGeneric (ANDA)
ANDA 088304 · CENCI
- 1983BELIXGeneric (ANDA)
ANDA 086586 · HALSEY
- 1983DIPHENHYDRAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 087977 · LNK
- 1983DIPHENHYDRAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 087978 · LNK
- 1982DIPHENHYDRAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 087941 · CENCI
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.
