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Details for New Drug Application (NDA): 071170

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NDA 071170 describes BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE, which is a drug marketed by Septodont and Hospira and is included in eight NDAs. It is available from six 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. 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: 071170

Tradename:
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
Applicant:
Hospira
Ingredient:
bupivacaine hydrochloride; epinephrine
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 071170

Suppliers and Packaging for NDA: 071170

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
bupivacaine hydrochloride; epinephrine
INJECTABLE;INJECTION 071170 ANDA Hospira, Inc. 0409-9046 0409-9046-01 25 CARTON in 1 CARTON (0409-9046-01) > 1 VIAL, MULTI-DOSE in 1 CARTON (0409-9046-11) > 50 mL in 1 VIAL, MULTI-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.5%;0.005MG/ML
Approval Date:Jun 16, 1988TE:APRLD:No


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