Orange Book product · Brand (NDA)
DIZAC
DIAZEPAM
At a glance
Jun 18, 1993
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 18, 1993
33 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
DIAZEPAM
Strength
5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 019287
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 2020VALTOCOBrand (NDA)
NDA 211635 · NEURELIS INC
- 1997DIASTATBrand (NDA)
NDA 020648 · BAUSCH
- 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
- 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.
