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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 071165


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NDA 071165 describes BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE, which is a drug marketed by Hospira and is included in eight NDAs. It is available from two suppliers. Additional details are available on the BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE profile page.

The generic ingredient in BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE is bupivacaine hydrochloride; epinephrine bitartrate. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride; epinephrine bitartrate profile page.
Summary for 071165
Pharmacology for NDA: 071165
Suppliers and Packaging for NDA: 071165
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE bupivacaine hydrochloride; epinephrine INJECTABLE;INJECTION 071165 ANDA Henry Schein, Inc. 0404-9828 0404-9828-30 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9828-30) / 30 mL in 1 VIAL, SINGLE-DOSE
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE bupivacaine hydrochloride; epinephrine INJECTABLE;INJECTION 071165 ANDA Hospira, Inc. 0409-9042 0409-9042-01 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-9042-01) / 10 mL in 1 VIAL, SINGLE-DOSE (0409-9042-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.25%;0.005MG/ML
Approval Date:Jun 16, 1988TE:RLD:No

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