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Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
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Generated: July 26, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203895

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NDA 203895 describes BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE, which is a drug marketed by Intl Medicated, Sagent Agila, and Aurobindo Pharma Ltd, and is included in three NDAs. It is available from two suppliers. Additional details are available on the BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE profile page.

The generic ingredient in BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE is bupivacaine hydrochloride. There are ten drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride profile page.

Summary for NDA: 203895

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

Pharmacology for NDA: 203895

Ingredient-typeAmides
Physiological EffectLocal Anesthesia

Suppliers and Packaging for NDA: 203895

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
bupivacaine hydrochloride
INJECTABLE;INJECTION 203895 ANDA AuroMedics Pharma LLC 55150-167 55150-167-10 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-167-10) > 10 mL in 1 VIAL, SINGLE-DOSE
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
bupivacaine hydrochloride
INJECTABLE;INJECTION 203895 ANDA AuroMedics Pharma LLC 55150-168 55150-168-30 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-168-30) > 30 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.25%
Approval Date:Nov 5, 2013TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.5%
Approval Date:Nov 5, 2013TE:APRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.75%
Approval Date:Nov 5, 2013TE:APRLD:No


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Serving 500+ biopharmaceutical companies globally:

Julphar
Harvard Business School
UBS
Novartis
US Department of Justice
Citi
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Queensland Health
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Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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