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Details for New Drug Application (NDA): 075324

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NDA 075324 describes MIDAZOLAM HYDROCHLORIDE, which is a drug marketed by Hospira Inc, Wockhardt, Apotex Inc, Apothecon, Intl Medication, Eurohlth Intl Sarl, Claris, Intl Medicated, Bedford, Gland Pharma Ltd, Fresenius Kabi Usa, Ben Venue, Hospira, Hi Tech Pharma, Sun Pharm Inds Ltd, Igi Labs Inc, Roxane, Paddock Llc, Akorn Inc, and Sagent Strides, and is included in thirty-two NDAs. It is available from nineteen suppliers. Additional details are available on the MIDAZOLAM HYDROCHLORIDE profile page.

The generic ingredient in MIDAZOLAM HYDROCHLORIDE is midazolam hydrochloride. There are nine drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the midazolam hydrochloride profile page.

Summary for NDA: 075324

Tradename:
MIDAZOLAM HYDROCHLORIDE
Applicant:
Eurohlth Intl Sarl
Ingredient:
midazolam hydrochloride
Patents:0
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1MG BASE/ML
Approval Date:Jun 20, 2000TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 5MG BASE/ML
Approval Date:Jun 20, 2000TE:APRLD:No


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