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FDA Orange Book · active-ingredient family

Midazolam hydrochloride

Midazolam hydrochloride is approved as 4 brand and 36 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR) · NDA 216359

4

Brand (NDA)

36

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable, solution, syrup

ProductApplicantApplicationTEApproved
MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)RLDRAFA LABS LTDNDA 216359—Aug 08, 2022
SEIZALAMRLDMMTNDA 209566—Sep 14, 2018
VERSEDRLDROCHENDA 020942—Oct 15, 1998
VERSEDRLD×2HLRNDA 018654—May 26, 1987

Generic (ANDA) products (36)

ProductApplicantApplicationTEApproved
MIDAZOLAM HYDROCHLORIDE×2MICRO LABSANDA 217504APAug 21, 2023
MIDAZOLAM HYDROCHLORIDE×2HIKMAANDA 212847APDec 11, 2020
MIDAZOLAM HYDROCHLORIDEFRESENIUS KABI USAANDA 208878—Mar 28, 2017
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE×2FRESENIUS KABI USAANDA 203460APAug 22, 2014
MIDAZOLAM HYDROCHLORIDEGLAND PHARMA LTDANDA 090696APFeb 29, 2012
MIDAZOLAM HYDROCHLORIDEGLAND PHARMA LTDANDA 090850APJan 25, 2012
MIDOZALAM HYDROCHLORIDE×2ONESOURCE SPECIALTYANDA 090316APMay 04, 2011
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE×2ONESOURCE SPECIALTYANDA 090315APNov 29, 2010
MIDAZOLAM HYDROCHLORIDE×2PH HEALTHANDA 078511—Nov 10, 2008
MIDAZOLAM HYDROCHLORIDE×2PH HEALTHANDA 078141—May 30, 2008
MIDAZOLAM HYDROCHLORIDEPHARM ASSOCANDA 077115—Sep 09, 2005
MIDAZOLAM HYDROCHLORIDEPADAGIS USANDA 076379AAMay 02, 2005
MIDAZOLAM HYDROCHLORIDE×2INTL MEDICATEDANDA 076144—Jan 26, 2005
MIDAZOLAM HYDROCHLORIDE×2INTL MEDICATIONANDA 076020—Jul 16, 2004
MIDAZOLAM HYDROCHLORIDEPAI HOLDINGSANDA 075958—Sep 04, 2003
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE×2HOSPIRAANDA 075857APJul 22, 2002
MIDAZOLAM HYDROCHLORIDE×2HOSPIRAANDA 075856—Jun 13, 2002
MIDAZOLAM HYDROCHLORIDEHIKMAANDA 075873AAApr 30, 2002
MIDAZOLAM HYDROCHLORIDESUN PHARM INDS LTDANDA 076058—Mar 15, 2002
MIDAZOLAM HYDROCHLORIDE×2APOTHECONANDA 075620—Nov 01, 2000
MIDAZOLAM HYDROCHLORIDE×2BAXTER HLTHCARE CORPANDA 075637—Oct 31, 2000
MIDAZOLAM HYDROCHLORIDEAPOTHECONANDA 075641—Oct 19, 2000
MIDAZOLAM HYDROCHLORIDEEPIC PHARMA LLCANDA 075481—Jun 30, 2000
MIDAZOLAM HYDROCHLORIDE×2RISINGANDA 075494APJun 30, 2000
MIDAZOLAM HYDROCHLORIDEIGI LABS INCANDA 075263—Jun 26, 2000
MIDAZOLAM HYDROCHLORIDEBEDFORDANDA 075249—Jun 23, 2000
MIDAZOLAM HYDROCHLORIDE×2HIKMAANDA 075247APJun 23, 2000
MIDAZOLAM HYDROCHLORIDEBEN VENUEANDA 075455—Jun 20, 2000
MIDAZOLAM HYDROCHLORIDE×2FRESENIUS KABI USAANDA 075154APJun 20, 2000
MIDAZOLAM HYDROCHLORIDE×2HIKMAANDA 075243APJun 20, 2000
MIDAZOLAM HYDROCHLORIDE×2HIKMAANDA 075324APJun 20, 2000
MIDAZOLAM HYDROCHLORIDE×2HIKMAANDA 075421APJun 20, 2000
MIDAZOLAM HYDROCHLORIDE×2HOSPIRAANDA 075293APJun 20, 2000
MIDAZOLAM HYDROCHLORIDE×2HOSPIRAANDA 075396—Jun 20, 2000
MIDAZOLAM HYDROCHLORIDEHOSPIRAANDA 075484—Jun 20, 2000
MIDAZOLAM HYDROCHLORIDE×2HOSPIRA INCANDA 075409—Jun 20, 2000

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.

Midazolam hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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