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Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078511

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NDA 078511 describes MIDAZOLAM HYDROCHLORIDE, which is a drug marketed by Akorn Inc, Apothecon, Baxter Hlthcare Corp, Bedford, Ben Venue, Fresenius Kabi Usa, Gland Pharma Ltd, Hospira, Hospira Inc, Igi Labs Inc, Intl Medicated, Intl Medication, West-ward Pharms Int, Wockhardt, Apotex Inc, Hi Tech Pharma, Paddock Llc, Sun Pharm Inds Ltd, and Sagent Agila Llc, and is included in thirty-three NDAs. It is available from twenty-one suppliers. Additional details are available on the MIDAZOLAM HYDROCHLORIDE profile page.

The generic ingredient in MIDAZOLAM 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 078511
Tradename:MIDAZOLAM HYDROCHLORIDE
Applicant:Wockhardt
Ingredient:midazolam hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078511
Ingredient-typeBenzodiazepines
Suppliers and Packaging for NDA: 078511
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MIDAZOLAM HYDROCHLORIDE midazolam hydrochloride INJECTABLE;INJECTION 078511 ANDA Wockhardt Limited 55648-764 55648-764-02 10 VIAL in 1 CARTON (55648-764-02) > 5 mL in 1 VIAL (55648-764-06)
MIDAZOLAM HYDROCHLORIDE midazolam hydrochloride INJECTABLE;INJECTION 078511 ANDA Wockhardt Limited 55648-764 55648-764-01 10 VIAL in 1 CARTON (55648-764-01) > 2 mL in 1 VIAL (55648-764-05)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 1MG BASE/ML
Approval Date:Nov 10, 2008TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 5MG BASE/ML
Approval Date:Nov 10, 2008TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
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