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Serving leading biopharmaceutical companies globally:

Queensland Health
US Army
Express Scripts

Generated: February 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203895

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NDA 203895 describes BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE, which is a drug marketed by Aurobindo Pharma Ltd, Intl Medicated, and Mylan Asi, and is included in three NDAs. It is available from two suppliers. Additional details are available on the BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE profile page.

The generic ingredient in BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE is bupivacaine hydrochloride. There are eleven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride profile page.
Summary for 203895
Applicant:Aurobindo Pharma Ltd
Ingredient:bupivacaine hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 203895
Physiological EffectLocal Anesthesia
Suppliers and Packaging for NDA: 203895
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE bupivacaine hydrochloride INJECTABLE;INJECTION 203895 ANDA AuroMedics Pharma LLC 55150-167 N 55150-167-10
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE bupivacaine hydrochloride INJECTABLE;INJECTION 203895 ANDA AuroMedics Pharma LLC 55150-168 N 55150-168-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.25%
Approval Date:Nov 5, 2013TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.5%
Approval Date:Nov 5, 2013TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.75%
Approval Date:Nov 5, 2013TE:APRLD:No

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