Orange Book product · Generic (ANDA)
DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE
At a glance
Aug 22, 2018
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 22, 2018
7 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
DIPHENHYDRAMINE HYDROCHLORIDE
Strength
50MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 205723
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DIPHENHYDRAMINE HYDROCHLORIDE
- —BENADRYLBrand (NDA)
NDA 005845 · MCNEIL CONS
- 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
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.
