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Generated: April 29, 2017

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Details for New Drug Application (NDA): 090315

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NDA 090315 describes MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE, which is a drug marketed by Sagent Strides, Hospira, and Fresenius Kabi Usa, 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-five suppliers are listed for this compound. Additional details are available on the midazolam hydrochloride profile page.

Summary for NDA: 090315

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 090315

Ingredient-typeBenzodiazepines

Suppliers and Packaging for NDA: 090315

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE
midazolam hydrochloride
INJECTABLE;INJECTION 090315 ANDA Sagent Pharmaceuticals 25021-655 25021-655-02 10 VIAL in 1 CARTON (25021-655-02) > 2 mL in 1 VIAL
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE
midazolam hydrochloride
INJECTABLE;INJECTION 090315 ANDA Sagent Pharmaceuticals 25021-655 25021-655-05 10 VIAL in 1 CARTON (25021-655-05) > 5 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1MG BASE/ML
Approval Date:Nov 29, 2010TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 5MG BASE/ML
Approval Date:Nov 29, 2010TE:APRLD:No


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