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Generated: November 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050575

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NDA 050575 describes AUGMENTIN '250', which is a drug marketed by Dr Reddys Labs Inc and is included in three NDAs. It is available from five suppliers. Additional details are available on the AUGMENTIN '250' profile page.

The generic ingredient in AUGMENTIN '250' 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 050575

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

Pharmacology for NDA: 050575

Ingredient-typePenicillins
Mechanism of Actionbeta Lactamase Inhibitors

Suppliers and Packaging for NDA: 050575

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AUGMENTIN '125'
amoxicillin; clavulanate potassium
FOR SUSPENSION;ORAL 050575 NDA Rebel Distributors Corp 42254-282 42254-282-00 100 mL in 1 BOTTLE (42254-282-00)
AUGMENTIN '125'
amoxicillin; clavulanate potassium
FOR SUSPENSION;ORAL 050575 NDA Dr. Reddy's Laboratories Inc 43598-004 43598-004-51 75 mL in 1 BOTTLE (43598-004-51)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength125MG/5ML;EQ 31.25MG BASE/5ML
Approval Date:Aug 6, 1984TE:ABRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength250MG/5ML;EQ 62.5MG BASE/5ML
Approval Date:Aug 6, 1984TE:ABRLD:Yes


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Serving leading biopharmaceutical companies globally:

Merck
Queensland Health
Boehringer Ingelheim
Dow
Baxter
Cipla
Argus Health
Healthtrust
Moodys
Farmers Insurance

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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