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Generated: October 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207183

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NDA 207183 describes BUPIVACAINE HYDROCHLORIDE, which is a drug marketed by Sagent Agila, Hospira, Baxter Hlthcare Corp, 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: 207183

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 207183

Ingredient-typeAmides
Physiological EffectLocal Anesthesia

Suppliers and Packaging for NDA: 207183

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUPIVACAINE HYDROCHLORIDE
bupivacaine hydrochloride
INJECTABLE;INJECTION 207183 ANDA AuroMedics Pharma LLC 55150-249 55150-249-50 25 VIAL, MULTI-DOSE in 1 CARTON (55150-249-50) > 50 mL in 1 VIAL, MULTI-DOSE
BUPIVACAINE HYDROCHLORIDE
bupivacaine hydrochloride
INJECTABLE;INJECTION 207183 ANDA AuroMedics Pharma LLC 55150-250 55150-250-50 25 VIAL, MULTI-DOSE in 1 CARTON (55150-250-50) > 50 mL in 1 VIAL, MULTI-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.25%
Approval Date:May 13, 2016TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.5%
Approval Date:May 13, 2016TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

Deloitte
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Harvard Business School
Johnson and Johnson
Teva
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Healthtrust
UBS
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