Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Check market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090316

« Back to Dashboard
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-five suppliers are listed for this compound. Additional details are available on the midazolam hydrochloride profile page.

Summary for NDA: 090316

Sagent Strides
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
midazolam hydrochloride
INJECTABLE;INJECTION 090316 ANDA Sagent Pharmaceuticals 25021-660 25021-660-10 10 VIAL in 1 CARTON (25021-660-10) > 10 mL in 1 VIAL
midazolam hydrochloride
INJECTABLE;INJECTION 090316 ANDA Sagent Pharmaceuticals 25021-661 25021-661-05 10 VIAL in 1 CARTON (25021-661-05) > 5 mL in 1 VIAL

Summary for product number 001

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

Summary for product number 002

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

Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.