Orange Book product · Generic (ANDA)
DIAZEPAM
DIAZEPAM
At a glance
Mar 18, 2019
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 18, 2019
7 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
DIAZEPAM
Strength
10MG/2ML (5MG/ML)
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 210363
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
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
- 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
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.
