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Details for New Drug Application (NDA): 204030

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NDA 204030 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, Apotex Inc, Sandoz Inc, Wockhardt Eu Operatn, and Teva Pharms Usa, and is included in seventy-three 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-two drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.

Summary for NDA: 204030

Aurobindo Pharma Ltd
Therapeutic Class:Antibacterials

Pharmacology for NDA: 204030


Suppliers and Packaging for NDA: 204030

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FOR SUSPENSION;ORAL 204030 ANDA Aurobindo Pharma Limited 65862-706 65862-706-01 100 mL in 1 BOTTLE (65862-706-01)
FOR SUSPENSION;ORAL 204030 ANDA Aurobindo Pharma Limited 65862-706 65862-706-55 150 mL in 1 BOTTLE (65862-706-55)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength125MG/5ML
Approval Date:Sep 15, 2014TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength250MG/5ML
Approval Date:Sep 15, 2014TE:ABRLD:No

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