Orange Book product · Generic (ANDA)
DIAZEPAM
DIAZEPAM
At a glance
Nov 14, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 14, 2025
7 mo ago
Today
Pharmaceutical detail
Active ingredient
DIAZEPAM
Strength
2.5MG/0.5ML (5MG/ML)
Dosage form
GEL
Route
RECTAL
TE code
AB
Application
ANDA 217468
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DIAZEPAM
- 2020VALTOCOBrand (NDA)
NDA 211635 · NEURELIS INC
- 1997DIASTATBrand (NDA)
NDA 020648 · BAUSCH
- 1993DIZACBrand (NDA)
NDA 019287 · PHARMACIA AND UPJOHN
- 1990DIAZEPAMBrand (NDA)
NDA 020124 · US ARMY
- —VALRELEASEBrand (NDA)
NDA 018179 · ROCHE
- —VALIUMBrand (NDA)
NDA 016087 · ROCHE
- 2025DIAZEPAMGeneric (ANDA)
ANDA 216422 · GALENICUM HLTH
- 2024DIAZEPAMGeneric (ANDA)
ANDA 217178 · LONG GROVE PHARMS
- 2024DIAZEPAMGeneric (ANDA)
ANDA 218422 · DR REDDYS
- 2024DIAZEPAMGeneric (ANDA)
ANDA 218450 · ALEMBIC
- 2023DIAZEPAMGeneric (ANDA)
ANDA 217843 · AUROBINDO PHARMA LTD
- 2023DIAZEPAMGeneric (ANDA)
ANDA 091076 · NOVEL LABS INC
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.
