Details for New Drug Application (NDA): 050755
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NDA 050755 describes AUGMENTIN ES-600, which is a drug marketed by Us Antibiotics and is included in one NDA. It is available from two suppliers. Additional details are available on the AUGMENTIN ES-600 profile page.
The generic ingredient in AUGMENTIN ES-600 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.
The generic ingredient in AUGMENTIN ES-600 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 050755
| Tradename: | AUGMENTIN ES-600 |
| Applicant: | Us Antibiotics |
| Ingredient: | amoxicillin; clavulanate potassium |
| Patents: | 0 |
Pharmacology for NDA: 050755
| Mechanism of Action | beta Lactamase Inhibitors |
Suppliers and Packaging for NDA: 050755
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AUGMENTIN ES-600 | amoxicillin; clavulanate potassium | FOR SUSPENSION;ORAL | 050755 | NDA AUTHORIZED GENERIC | RPK Pharmaceuticals, Inc. | 53002-4716 | 53002-4716-1 | 200 mL in 1 BOTTLE (53002-4716-1) |
| AUGMENTIN ES-600 | amoxicillin; clavulanate potassium | FOR SUSPENSION;ORAL | 050755 | NDA AUTHORIZED GENERIC | RPK Pharmaceuticals, Inc. | 53002-4716 | 53002-4716-2 | 75 mL in 1 BOTTLE (53002-4716-2) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 600MG/5ML;EQ 42.9MG BASE/5ML | ||||
| Approval Date: | Jun 22, 2001 | TE: | AB | RLD: | Yes | ||||
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