Orange Book product · Brand (NDA)
MIDAZOLAM IN 0.9% SODIUM CHLORIDE
MIDAZOLAM
Brand (NDA)NDA 211844TE APRX INFORLIFE
At a glance
Mar 22, 2021
Approved
Brand (NDA)
Application
AP
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 22, 2021
5 yr 4 mo ago
Today
Patent 10966990 expires
Listed drug product patent expiration.
Jun 20, 2038
in 12 yr 2 mo
Pharmaceutical detail
Active ingredient
MIDAZOLAM
Strength
50MG/50ML (1MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
AP
Application
NDA 211844
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 2022MIDAZOLAM IN 0.8% SODIUM CHLORIDEBrand (NDA)
NDA 215868 · EXELA PHARMA
- 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 (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10966990 | Jun 20, 2038 | in 12 yr 2 mo | Product |
