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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Fuji
Novartis
Merck
US Army
Johnson and Johnson
QuintilesIMS
Queensland Health
Citi
Argus Health
Moodys

Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050564

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NDA 050564 describes AUGMENTIN '500', which is a drug marketed by Dr Reddys Labs Inc and is included in one NDA. It is available from four suppliers. Additional details are available on the AUGMENTIN '500' profile page.

The generic ingredient in AUGMENTIN '500' is amoxicillin; clavulanate potassium. There are forty-four drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.

Summary for 050564

Tradename:2
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 050564

Ingredient-typePenicillins
Mechanism of Actionbeta Lactamase Inhibitors

Suppliers and Packaging for NDA: 050564

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AUGMENTIN '250' amoxicillin; clavulanate potassium TABLET;ORAL 050564 NDA Dr. Reddy's Laboratories Inc 43598-006 43598-006-78 100 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (43598-006-78)
AUGMENTIN '250' amoxicillin; clavulanate potassium TABLET;ORAL 050564 NDA Dr. Reddy's Laboratories Inc 43598-006 43598-006-14 20 TABLET, FILM COATED in 1 BOTTLE (43598-006-14)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Aug 6, 1984TE:RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Aug 6, 1984TE:RLD:Yes


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Serving leading biopharmaceutical companies globally:

Fuji
Baxter
Julphar
UBS
US Army
Harvard Business School
Healthtrust
Deloitte
Medtronic
Chubb

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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