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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-one suppliers are listed for this compound. Additional details are available on the midazolam hydrochloride profile page.

Summary for NDA: 090316

Sagent Strides
midazolam hydrochloride

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

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