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Serving 500+ biopharmaceutical companies globally:

US Department of Justice
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Citi
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Generated: June 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050460

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NDA 050460 describes LAROTID, which is a drug marketed by Dr Reddys Labs Inc and Glaxosmithkline and is included in two NDAs. It is available from one supplier. Additional details are available on the LAROTID profile page.

The generic ingredient in LAROTID is amoxicillin. There are forty-four drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the amoxicillin profile page.

Summary for NDA: 050460

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

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:FOR SUSPENSION;ORALStrength125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:FOR SUSPENSION;ORALStrength250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Summary for product number 005

Active Rx/OTC/Discontinued:DISCNDosage:FOR SUSPENSION;ORALStrength50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes


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Serving 500+ biopharmaceutical companies globally:

Fuji
UBS
Chinese Patent Office
Queensland Health
US Department of Justice
Baxter
Citi
Healthtrust
McKinsey
Medtronic

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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