Details for New Drug Application (NDA): 050760
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NDA 050760 describes AMOXIL, which is a drug marketed by Glaxosmithkline and Us Antibiotics and is included in eight NDAs. It is available from three suppliers. Additional details are available on the AMOXIL profile page.
The generic ingredient in AMOXIL is amoxicillin. There are forty-six drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the amoxicillin profile page.
The generic ingredient in AMOXIL is amoxicillin. There are forty-six drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the amoxicillin profile page.
Summary for 050760
| Tradename: | AMOXIL |
| Applicant: | Us Antibiotics |
| Ingredient: | amoxicillin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 050760
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMOXIL | amoxicillin | FOR SUSPENSION;ORAL | 050760 | NDA | Proficient Rx LP | 63187-027 | 63187-027-00 | 100 mL in 1 BOTTLE (63187-027-00) |
| AMOXIL | amoxicillin | FOR SUSPENSION;ORAL | 050760 | NDA | USAntibiotics, LLC | 81964-207 | 81964-207-50 | 50 mL in 1 BOTTLE (81964-207-50) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | FOR SUSPENSION;ORAL | Strength | 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Apr 15, 1999 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 400MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Apr 15, 1999 | TE: | AB | RLD: | Yes | ||||
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