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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Cantor Fitzgerald
Federal Trade Commission
Harvard Business School

Generated: March 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 070584

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NDA 070584 describes BUPIVACAINE HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma Ltd, Hospira, Mylan Asi, Baxter Hlthcare Corp, Septodont, and Intl Medicated, and is included in twenty-six NDAs. It is available from five suppliers. Additional details are available on the BUPIVACAINE HYDROCHLORIDE profile page.

The generic ingredient in BUPIVACAINE HYDROCHLORIDE is bupivacaine hydrochloride; epinephrine bitartrate. There are eleven drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride; epinephrine bitartrate profile page.
Summary for 070584
Ingredient:bupivacaine hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 070584
Physiological EffectLocal Anesthesia
Suppliers and Packaging for NDA: 070584
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUPIVACAINE HYDROCHLORIDE bupivacaine hydrochloride INJECTABLE;INJECTION 070584 ANDA Hospira, Inc. 0409-1162 N 0409-1162-02
BUPIVACAINE HYDROCHLORIDE bupivacaine hydrochloride INJECTABLE;INJECTION 070584 ANDA Hospira, Inc. 0409-1162 N 0409-1162-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.5%
Approval Date:Feb 17, 1986TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Federal Trade Commission
Johnson and Johnson

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