➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Express Scripts

Last Updated: May 30, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207183

Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

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
Applicant:Aurobindo Pharma Ltd
Ingredient:bupivacaine hydrochloride
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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.