Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Generated: July 21, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 070583

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NDA 070583 describes BUPIVACAINE HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma Ltd, Hospira, Mylan Asi, Novocol Healthcare, B Braun Medical Inc, Baxter Hlthcare Corp, Septodont, and Intl Medicated, and is included in twenty-eight NDAs. It is available from nine suppliers. Additional details are available on the BUPIVACAINE HYDROCHLORIDE profile page.

The generic ingredient in BUPIVACAINE HYDROCHLORIDE is bupivacaine hydrochloride; epinephrine bitartrate. There are twelve 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 070583
Tradename:BUPIVACAINE HYDROCHLORIDE
Applicant:Hospira
Ingredient:bupivacaine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 070583
Physiological EffectLocal Anesthesia
Suppliers and Packaging for NDA: 070583
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUPIVACAINE HYDROCHLORIDE bupivacaine hydrochloride INJECTABLE;INJECTION 070583 ANDA Hospira, Inc. 0409-1159 0409-1159-10 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1159-10) > 30 mL in 1 VIAL, SINGLE-DOSE (0409-1159-09)
BUPIVACAINE HYDROCHLORIDE bupivacaine hydrochloride INJECTABLE;INJECTION 070583 ANDA Hospira, Inc. 0409-1159 0409-1159-01 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1159-01) > 10 mL in 1 VIAL, SINGLE-DOSE (0409-1159-18)

Profile for product number 001

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

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