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Generated: December 18, 2018

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Details for New Drug Application (NDA): 075857

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NDA 075857 describes MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE, which is a drug marketed by Fresenius Kabi Usa, Hospira, and Mylan Asi, and is included in three NDAs. It is available from six suppliers. Additional details are available on the MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE profile page.

The generic ingredient in MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE is midazolam hydrochloride. There are nine drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the midazolam hydrochloride profile page.
Summary for 075857
Tradename:MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE
Applicant:Hospira
Ingredient:midazolam hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 075857
Suppliers and Packaging for NDA: 075857
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE midazolam hydrochloride INJECTABLE;INJECTION 075857 ANDA Hospira, Inc. 0409-2305 0409-2305-05 10 VIAL, SINGLE-DOSE in 1 BOX (0409-2305-05) > 5 mL in 1 VIAL, SINGLE-DOSE
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE midazolam hydrochloride INJECTABLE;INJECTION 075857 ANDA Hospira, Inc. 0409-2305 0409-2305-17 25 VIAL, SINGLE-DOSE in 1 BOX (0409-2305-17) > 2 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1MG BASE/ML
Approval Date:Jul 22, 2002TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 5MG BASE/ML
Approval Date:Jul 22, 2002TE:APRLD:No

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