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Midazolamis the generic ingredient in six branded drugs marketed by Ucb Inc, Akorn Inc, Apothecon, Atlantide, Baxter Hlthcare Corp, Bedford, Ben Venue, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Hospira Inc, Igi Labs Inc, Intl Medicated, Intl Medication, West-ward Pharms Int, Mylan Asi, HLR, Meridian Medcl Techn, Akorn, Paddock Llc, Pharm Assoc, Sun Pharm Inds Ltd, and Roche, and is included in thirty-nine NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.
There are nine drug master file entries for midazolam. One supplier is listed for this compound. There is one tentative approval for this compound.
Summary for midazolam
|Drug Master File Entries:||9|
|Suppliers / Packagers:||1|
|Bulk Api Vendors:||38|
|Formulation / Manufacturing:||see details|
|Drug Prices:||Drug price trends for midazolam|
|What excipients (inactive ingredients) are in midazolam?||midazolam excipients list|
|DailyMed Link:||midazolam at DailyMed|
Recent Clinical Trials for midazolam
Identify potential brand extensions & 505(b)(2) entrants
|Rafa Laboratories||Phase 1|
|Joint Project Management Office for Chemical, Biological, Radiological, and Nuclear Medical||Phase 1|
|Ology Bioservices||Phase 1|
Generic filers with tentative approvals for MIDAZOLAM
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for midazolam
|Drug Class||Benzodiazepine |
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||TE||Type||RLD||RS||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|Ucb Inc||NAYZILAM||midazolam||SPRAY;NASAL||211321-001||May 17, 2019||RX||Yes||Yes||Start Trial||Start Trial||Start Trial|
|Mylan Asi||MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE||midazolam hydrochloride||INJECTABLE;INJECTION||090315-001||Nov 29, 2010||DISCN||No||No||Start Trial||Start Trial||Start Trial|
|Igi Labs Inc||MIDAZOLAM HYDROCHLORIDE||midazolam hydrochloride||INJECTABLE;INJECTION||075263-001||Jun 26, 2000||DISCN||No||No||Start Trial||Start Trial||Start Trial|
|Fresenius Kabi Usa||MIDAZOLAM HYDROCHLORIDE||midazolam hydrochloride||INJECTABLE;INJECTION||208878-001||Mar 28, 2017||RX||No||No||Start Trial||Start Trial||Start Trial|
|Apothecon||MIDAZOLAM HYDROCHLORIDE||midazolam hydrochloride||INJECTABLE;INJECTION||075641-001||Oct 19, 2000||DISCN||No||No||Start Trial||Start Trial||Start Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|
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