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Last Updated: July 2, 2020

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Details for New Drug Application (NDA): 070585


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NDA 070585 describes BUPIVACAINE HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma Ltd, Hospira, Mylan Asi, Novocol Healthcare, B Braun Medical Inc, Baxter Hlthcare Corp, Huons, Septodont, and Intl Medicated, and is included in twenty-nine NDAs. It is available from nine suppliers. Additional details are available on the BUPIVACAINE HYDROCHLORIDE profile page.

The generic ingredient in BUPIVACAINE HYDROCHLORIDE is bupivacaine hydrochloride; epinephrine bitartrate. There are twelve drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride; epinephrine bitartrate profile page.
Summary for 070585
Tradename:BUPIVACAINE HYDROCHLORIDE
Applicant:Hospira
Ingredient:bupivacaine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 070585
Physiological EffectLocal Anesthesia
Suppliers and Packaging for NDA: 070585
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUPIVACAINE HYDROCHLORIDE bupivacaine hydrochloride INJECTABLE;INJECTION 070585 ANDA Hospira, Inc. 0409-1165 0409-1165-01 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1165-01) > 10 mL in 1 VIAL, SINGLE-DOSE (0409-1165-18)
BUPIVACAINE HYDROCHLORIDE bupivacaine hydrochloride INJECTABLE;INJECTION 070585 ANDA Hospira, Inc. 0409-1165 0409-1165-02 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1165-02) > 30 mL in 1 VIAL, SINGLE-DOSE (0409-1165-19)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.75%
Approval Date:Mar 3, 1987TE:APRLD:No

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