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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 203895


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NDA 203895 describes BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE, which is a drug marketed by Eugia Pharma, Hikma Pharms, Intl Medicated, and Onesource Specialty, and is included in four NDAs. It is available from six 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 twelve drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride profile page.
Summary for 203895
Tradename:BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
Applicant:Eugia Pharma
Ingredient:bupivacaine hydrochloride
Patents:0
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 Eugia US LLC 55150-167 55150-167-10 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-167-10) / 10 mL in 1 VIAL, SINGLE-DOSE
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE bupivacaine hydrochloride INJECTABLE;INJECTION 203895 ANDA Eugia US LLC 55150-168 55150-168-30 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-168-30) / 30 mL in 1 VIAL, SINGLE-DOSE

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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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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