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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Johnson and Johnson
US Department of Justice
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Queensland Health
Cantor Fitzgerald

Generated: July 27, 2017

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Details for New Drug Application (NDA): 070584

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

The generic ingredient in BUPIVACAINE HYDROCHLORIDE is bupivacaine hydrochloride; epinephrine. There are ten drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride; epinephrine profile page.

Summary for NDA: 070584

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
INJECTABLE;INJECTION 070584 ANDA Hospira, Inc. 0409-1162 0409-1162-10 25 VIAL, SINGLE-USE in 1 TRAY (0409-1162-10) > 30 mL in 1 VIAL, SINGLE-USE (0409-1162-09)
bupivacaine hydrochloride
INJECTABLE;INJECTION 070584 ANDA Hospira, Inc. 0409-1162 0409-1162-01 25 VIAL, SINGLE-USE in 1 TRAY (0409-1162-01) > 10 mL in 1 VIAL, SINGLE-USE (0409-1162-18)

Summary for product number 001

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

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Serving 500+ biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim
Chinese Patent Office
US Army
Farmers Insurance

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