Orange Book product · Brand (NDA)
VERSED
MIDAZOLAM HYDROCHLORIDE
At a glance
Dec 20, 1985
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 20, 1985
41 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
MIDAZOLAM HYDROCHLORIDE
Strength
EQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 018654
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.
- 2022MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)Brand (NDA)
NDA 216359 · RAFA LABS LTD
- 2018SEIZALAMBrand (NDA)
NDA 209566 · MMT
- 1998VERSEDBrand (NDA)
NDA 020942 · ROCHE
- 2023MIDAZOLAM HYDROCHLORIDEGeneric (ANDA)
ANDA 217504 · MICRO LABS
- 2020MIDAZOLAM HYDROCHLORIDEGeneric (ANDA)
ANDA 212847 · HIKMA
- 2017MIDAZOLAM HYDROCHLORIDEGeneric (ANDA)
ANDA 208878 · FRESENIUS KABI USA
- 2014MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREEGeneric (ANDA)
ANDA 203460 · FRESENIUS KABI USA
- 2012MIDAZOLAM HYDROCHLORIDEGeneric (ANDA)
ANDA 090696 · GLAND PHARMA LTD
- 2012MIDAZOLAM HYDROCHLORIDEGeneric (ANDA)
ANDA 090850 · GLAND PHARMA LTD
- 2011MIDOZALAM HYDROCHLORIDEGeneric (ANDA)
ANDA 090316 · ONESOURCE SPECIALTY
- 2010MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREEGeneric (ANDA)
ANDA 090315 · ONESOURCE SPECIALTY
- 2008MIDAZOLAM HYDROCHLORIDEGeneric (ANDA)
ANDA 078511 · PH HEALTH
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.
