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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 201091


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NDA 201091 describes AMOXICILLIN AND CLAVULANATE POTASSIUM, which is a drug marketed by Aurobindo Pharma, Aurobindo Pharma Ltd, Deva Holding As, Hikma Pharms, Micro Labs, Micro Labs Ltd India, Sandoz, Sandoz Inc, Sun Pharm Inds Ltd, Teva, Wockhardt Bio Ag, Apotex Inc, and Teva Pharms Usa, and is included in forty-one NDAs. It is available from thirty-two suppliers. Additional details are available on the AMOXICILLIN AND CLAVULANATE POTASSIUM profile page.

The generic ingredient in AMOXICILLIN AND CLAVULANATE POTASSIUM is amoxicillin; clavulanate potassium. There are forty-six drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.
Summary for 201091
Pharmacology for NDA: 201091
Mechanism of Actionbeta Lactamase Inhibitors
Suppliers and Packaging for NDA: 201091
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium FOR SUSPENSION;ORAL 201091 ANDA NorthStar Rx LLC 16714-294 16714-294-01 75 mL in 1 BOTTLE (16714-294-01)
AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium FOR SUSPENSION;ORAL 201091 ANDA NorthStar Rx LLC 16714-294 16714-294-02 125 mL in 1 BOTTLE (16714-294-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength600MG/5ML;EQ 42.9MG BASE/5ML
Approval Date:Dec 20, 2011TE:ABRLD:No

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