Orange Book product · Brand (NDA)
DIASTAT
DIAZEPAM
At a glance
Jul 29, 1997
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 29, 1997
29 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
DIAZEPAM
Strength
10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
GEL
Route
RECTAL
TE code
Not listed
Application
NDA 020648
Product number
003
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2020VALTOCOBrand (NDA)
NDA 211635 · NEURELIS INC
- 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
- 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.
