Orange Book product · Generic (ANDA)
MIDAZOLAM IN 0.8% SODIUM CHLORIDE
MIDAZOLAM
Generic (ANDA)ANDA 218454RX B BRAUN MEDICAL
At a glance
May 01, 2025
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 01, 2025
1 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
MIDAZOLAM
Strength
50MG/50ML (1MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
ANDA 218454
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of MIDAZOLAM
- 2022MIDAZOLAM IN 0.8% SODIUM CHLORIDEBrand (NDA)
NDA 215868 · EXELA PHARMA
- 2021MIDAZOLAM IN 0.9% SODIUM CHLORIDEBrand (NDA)
NDA 211844 · INFORLIFE
- 2019NAYZILAMBrand (NDA)
NDA 211321 · UCB INC
- 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.
