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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
UBS
Colorcon
Deloitte
AstraZeneca
QuintilesIMS
Medtronic
Argus Health
Fuji
Express Scripts

Generated: October 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203460

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NDA 203460 describes MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE, which is a drug marketed by Sagent Agila Llc, 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-two suppliers are listed for this compound. Additional details are available on the midazolam hydrochloride profile page.

Summary for NDA: 203460

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 203460

Ingredient-typeBenzodiazepines

Suppliers and Packaging for NDA: 203460

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE
midazolam hydrochloride
INJECTABLE;INJECTION 203460 ANDA Fresenius Kabi USA, LLC 76045-001 76045-001-20 24 BLISTER PACK in 1 CARTON (76045-001-20) > 1 SYRINGE, GLASS in 1 BLISTER PACK > 2 mL in 1 SYRINGE, GLASS
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE
midazolam hydrochloride
INJECTABLE;INJECTION 203460 ANDA Fresenius Kabi USA, LLC 76045-002 76045-002-10 24 BLISTER PACK in 1 CARTON (76045-002-10) > 1 SYRINGE, GLASS in 1 BLISTER PACK > 1 mL in 1 SYRINGE, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1MG BASE/ML
Approval Date:Aug 22, 2014TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 5MG BASE/ML
Approval Date:Aug 22, 2014TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

Julphar
Harvard Business School
Argus Health
Fish and Richardson
Express Scripts
Medtronic
Colorcon
Chubb
Citi
Daiichi Sankyo

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