Orange Book product · Generic (ANDA)
DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE
At a glance
Aug 22, 2025
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 22, 2025
10 mo ago
Today
Pharmaceutical detail
Active ingredient
DIPHENHYDRAMINE HYDROCHLORIDE
Strength
50MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 219845
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.
