Details for New Drug Application (NDA): 050575
✉ Email this page to a colleague
NDA 050575 describes AUGMENTIN '250', which is a drug marketed by Us Antibiotics and is included in three NDAs. It is available from two suppliers. Additional details are available on the AUGMENTIN '250' profile page.
The generic ingredient in AUGMENTIN '250' is amoxicillin; clavulanate potassium. There are forty-six drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.
The generic ingredient in AUGMENTIN '250' is amoxicillin; clavulanate potassium. There are forty-six drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.
Summary for 050575
| Tradename: | AUGMENTIN '250' |
| Applicant: | Us Antibiotics |
| Ingredient: | amoxicillin; clavulanate potassium |
| Patents: | 0 |
Pharmacology for NDA: 050575
| Mechanism of Action | beta Lactamase Inhibitors |
Suppliers and Packaging for NDA: 050575
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AUGMENTIN '125' | amoxicillin; clavulanate potassium | FOR SUSPENSION;ORAL | 050575 | NDA | Allegis Holdings, LLC | 71297-240 | 71297-240-34 | 75 mL in 1 BOTTLE (71297-240-34) |
| AUGMENTIN '125' | amoxicillin; clavulanate potassium | FOR SUSPENSION;ORAL | 050575 | NDA | Allegis Holdings, LLC | 71297-240 | 71297-240-35 | 100 mL in 1 BOTTLE (71297-240-35) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 125MG/5ML;EQ 31.25MG BASE/5ML | ||||
| Approval Date: | Aug 6, 1984 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 250MG/5ML;EQ 62.5MG BASE/5ML | ||||
| Approval Date: | Aug 6, 1984 | TE: | AB | RLD: | Yes | ||||
Complete Access Available with Subscription
