Orange Book product · Generic (ANDA)
DIAZEPAM
DIAZEPAM
At a glance
May 19, 2025
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 19, 2025
1 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
DIAZEPAM
Strength
50MG/10ML (5MG/ML)
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 216422
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 217468 · NAVINTA LLC
- 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.
