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Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
Harvard Business School
Daiichi Sankyo
Cantor Fitzgerald
AstraZeneca
Argus Health
Novartis
Express Scripts
Federal Trade Commission
Boehringer Ingelheim

Generated: June 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201091

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NDA 201091 describes AMOXICILLIN AND CLAVULANATE POTASSIUM, which is a drug marketed by Teva, Sun Pharm Inds Ltd, Micro Labs Ltd India, Apotex Inc, Sandoz Inc, Wockhardt Eu Operatn, Hikma Pharms, Sandoz, Wockhardt, Aurobindo Pharma Ltd, and Teva Pharms Usa, and is included in thirty-three NDAs. It is available from forty-one suppliers. Additional details are available on the AMOXICILLIN AND CLAVULANATE POTASSIUM profile page.

The generic ingredient in AMOXICILLIN AND CLAVULANATE POTASSIUM is amoxicillin; clavulanate potassium. There are forty-four drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.

Summary for NDA: 201091

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 201091

Ingredient-typePenicillins
Mechanism of Actionbeta Lactamase Inhibitors

Suppliers and Packaging for NDA: 201091

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMOXICILLIN AND CLAVULANATE POTASSIUM
amoxicillin; clavulanate potassium
FOR SUSPENSION;ORAL 201091 ANDA NorthStar Rx LLC 16714-294 16714-294-01 75 mL in 1 BOTTLE (16714-294-01)
AMOXICILLIN AND CLAVULANATE POTASSIUM
amoxicillin; clavulanate potassium
FOR SUSPENSION;ORAL 201091 ANDA NorthStar Rx LLC 16714-294 16714-294-02 125 mL in 1 BOTTLE (16714-294-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength600MG/5ML;EQ 42.9MG BASE/5ML
Approval Date:Dec 20, 2011TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Fuji
Citi
Cerilliant
Johnson and Johnson
Harvard Business School
Chinese Patent Office
Healthtrust
McKesson
Teva
Daiichi Sankyo

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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