Orange Book product · Generic (ANDA)
MIDAZOLAM HYDROCHLORIDE
MIDAZOLAM HYDROCHLORIDE
At a glance
Dec 11, 2020
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 11, 2020
5 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
MIDAZOLAM HYDROCHLORIDE
Strength
EQ 1MG BASE/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 212847
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of MIDAZOLAM HYDROCHLORIDE
- 2022MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)Brand (NDA)
NDA 216359 · RAFA LABS LTD
- 2018SEIZALAMBrand (NDA)
NDA 209566 · MMT
- 1998VERSEDBrand (NDA)
NDA 020942 · ROCHE
- 1987VERSEDBrand (NDA)
NDA 018654 · HLR
- 2023MIDAZOLAM HYDROCHLORIDEGeneric (ANDA)
ANDA 217504 · MICRO LABS
- 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.
