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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 091487


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NDA 091487 describes BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE, which is a drug marketed by Eugia Pharma, Hikma Pharms, Intl Medicated, and Steriscience Speclts, and is included in four NDAs. It is available from five 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-one suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride profile page.
Summary for 091487
Pharmacology for NDA: 091487
Physiological EffectLocal Anesthesia
Suppliers and Packaging for NDA: 091487
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE bupivacaine hydrochloride INJECTABLE;INJECTION 091487 ANDA Xellia Pharmaceuticals USA LLC 70594-114 70594-114-02 10 VIAL in 1 CARTON (70594-114-02) / 10 mL in 1 VIAL (70594-114-01)
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE bupivacaine hydrochloride INJECTABLE;INJECTION 091487 ANDA Xellia Pharmaceuticals USA LLC 70594-115 70594-115-01 30 mL in 1 VIAL, SINGLE-DOSE (70594-115-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.5%
Approval Date:Oct 18, 2011TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.25%
Approval Date:Oct 18, 2011TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.75%
Approval Date:Oct 18, 2011TE:APRLD:No

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