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Last Updated: May 30, 2020

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Details for New Drug Application (NDA): 207183


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NDA 207183 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 ten 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 207183
Tradename:BUPIVACAINE HYDROCHLORIDE
Applicant:Aurobindo Pharma Ltd
Ingredient:bupivacaine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207183
Physiological EffectLocal Anesthesia
Suppliers and Packaging for NDA: 207183
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUPIVACAINE HYDROCHLORIDE bupivacaine hydrochloride INJECTABLE;INJECTION 207183 ANDA A-S Medication Solutions 50090-4516 50090-4516-0 50 mL in 1 VIAL, MULTI-DOSE (50090-4516-0)
BUPIVACAINE HYDROCHLORIDE bupivacaine hydrochloride INJECTABLE;INJECTION 207183 ANDA AuroMedics Pharma LLC 55150-249 55150-249-50 25 VIAL, MULTI-DOSE in 1 CARTON (55150-249-50) > 50 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.25%
Approval Date:May 13, 2016TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.5%
Approval Date:May 13, 2016TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

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Boehringer Ingelheim

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