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Serving 500+ biopharmaceutical companies globally:

Cipla
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Chinese Patent Office
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Covington

Generated: June 25, 2017

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Details for New Drug Application (NDA): 065119

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NDA 065119 describes AMOXICILLIN, which is a drug marketed by Teva, Sun Pharm Inds Ltd, Wockhardt, Hikma, Aurobindo Pharma Ltd, Dava Pharms Inc, Labs Atral, Sandoz, Apothecon, Aurobindo, Am Antibiotics, Mylan, Hikma Pharms, Micro Labs Ltd India, Apotex Inc, Sandoz Inc, Wockhardt Eu Operatn, and Teva Pharms Usa, and is included in seventy-five NDAs. It is available from fifty-two suppliers. Additional details are available on the AMOXICILLIN profile page.

The generic ingredient in AMOXICILLIN 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: 065119

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

Pharmacology for NDA: 065119

Ingredient-typePenicillins

Suppliers and Packaging for NDA: 065119

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMOXICILLIN
amoxicillin
 FOR SUSPENSION;ORAL 065119 ANDA Teva Pharmaceuticals USA Inc 0093-4160 0093-4160-73 100 mL in 1 BOTTLE (0093-4160-73)
AMOXICILLIN
amoxicillin
 FOR SUSPENSION;ORAL 065119 ANDA Teva Pharmaceuticals USA Inc 0093-4160 0093-4160-76 50 mL in 1 BOTTLE (0093-4160-76)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength200MG/5ML
Approval Date:Dec 4, 2002TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength400MG/5ML
Approval Date:Dec 4, 2002TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Merck
UBS
US Department of Justice
Dow
Argus Health
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Healthtrust
Baxter

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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