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Serving leading biopharmaceutical companies globally:

Express Scripts
Argus Health
Boehringer Ingelheim
US Army

Generated: February 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090316

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NDA 090316 describes MIDOZALAM HYDROCHLORIDE, which is a drug marketed by Sagent Strides and is included in one NDA. It is available from one supplier. Additional details are available on the MIDOZALAM HYDROCHLORIDE profile page.

The generic ingredient in MIDOZALAM HYDROCHLORIDE 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 090316
Applicant:Sagent Strides
Ingredient:midazolam hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 090316
Suppliers and Packaging for NDA: 090316
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MIDOZALAM HYDROCHLORIDE midazolam hydrochloride INJECTABLE;INJECTION 090316 ANDA Sagent Pharmaceuticals 25021-660 N 25021-660-10
MIDOZALAM HYDROCHLORIDE midazolam hydrochloride INJECTABLE;INJECTION 090316 ANDA Sagent Pharmaceuticals 25021-661 N 25021-661-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1MG BASE/ML
Approval Date:May 4, 2011TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 5MG BASE/ML
Approval Date:May 4, 2011TE:APRLD:No

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Chinese Patent Office
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Daiichi Sankyo

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