Orange Book product · Brand (NDA)
MIDAZOLAM IN 0.8% SODIUM CHLORIDE
MIDAZOLAM
At a glance
Jul 20, 2022
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 20, 2022
4 yr ago
Today
Pharmaceutical detail
Active ingredient
MIDAZOLAM
Strength
50MG/50ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 215868
Product number
001
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.
- 2021MIDAZOLAM IN 0.9% SODIUM CHLORIDEBrand (NDA)
NDA 211844 · INFORLIFE
- 2019NAYZILAMBrand (NDA)
NDA 211321 · UCB INC
- 2025MIDAZOLAM IN 0.8% SODIUM CHLORIDEGeneric (ANDA)
ANDA 218454 · B BRAUN MEDICAL
- 2024MIDAZOLAM IN 0.9% SODIUM CHLORIDEGeneric (ANDA)
ANDA 218993 · GLAND
- 2023MIDAZOLAM IN 0.9% SODIUM CHLORIDEGeneric (ANDA)
ANDA 216159 · HIKMA
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.
