Details for New Drug Application (NDA): 209371
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The generic ingredient in AMOXICILLIN AND CLAVULANATE POTASSIUM is amoxicillin; clavulanate potassium. There are forty-six drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.
Summary for 209371
Tradename: | AMOXICILLIN AND CLAVULANATE POTASSIUM |
Applicant: | Aurobindo Pharma |
Ingredient: | amoxicillin; clavulanate potassium |
Patents: | 0 |
Pharmacology for NDA: 209371
Mechanism of Action | beta Lactamase Inhibitors |
Suppliers and Packaging for NDA: 209371
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMOXICILLIN AND CLAVULANATE POTASSIUM | amoxicillin; clavulanate potassium | FOR SUSPENSION;ORAL | 209371 | ANDA | Aurobindo Pharma Limited | 59651-025 | 59651-025-01 | 100 mL in 1 BOTTLE (59651-025-01) |
AMOXICILLIN AND CLAVULANATE POTASSIUM | amoxicillin; clavulanate potassium | FOR SUSPENSION;ORAL | 209371 | ANDA | Aurobindo Pharma Limited | 59651-025 | 59651-025-55 | 150 mL in 1 BOTTLE (59651-025-55) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 125MG/5ML;EQ 31.25MG BASE/5ML | ||||
Approval Date: | Apr 19, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 250MG/5ML;EQ 62.5MG BASE/5ML | ||||
Approval Date: | Apr 19, 2019 | TE: | AB | RLD: | No |
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