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Details for New Drug Application (NDA): 070590

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NDA 070590 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: 070590

Formulation / Manufacturing:see details

Pharmacology for NDA: 070590

Physiological EffectLocal Anesthesia

Suppliers and Packaging for NDA: 070590

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
bupivacaine hydrochloride
INJECTABLE;INJECTION 070590 ANDA Hospira, Inc. 0409-1160 0409-1160-01 25 VIAL, MULTI-DOSE in 1 TRAY (0409-1160-01) > 50 mL in 1 VIAL, MULTI-DOSE (0409-1160-18)
bupivacaine hydrochloride
INJECTABLE;INJECTION 070590 ANDA General Injectables & Vaccines, Inc 52584-160 52584-160-01 1 VIAL, MULTI-DOSE in 1 BAG (52584-160-01) > 50 mL in 1 VIAL, MULTI-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.25%
Approval Date:Feb 17, 1987TE:APRLD:No

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