Orange Book product · Generic (ANDA)
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE
MIDAZOLAM HYDROCHLORIDE
At a glance
Jul 22, 2002
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 22, 2002
24 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
MIDAZOLAM HYDROCHLORIDE
Strength
EQ 5MG BASE/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 075857
Product number
002
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
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
- 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
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.
