Details for New Drug Application (NDA): 062216
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NDA 062216 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 062216
| Tradename: | AMOXIL |
| Applicant: | Us Antibiotics |
| Ingredient: | amoxicillin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 062216
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMOXIL | amoxicillin | CAPSULE;ORAL | 062216 | ANDA | Redpharm Drug | 67296-1914 | 67296-1914-3 | 30 CAPSULE in 1 BOTTLE (67296-1914-3) |
| AMOXIL | amoxicillin | CAPSULE;ORAL | 062216 | ANDA | USAntibiotics, LLC | 81964-205 | 81964-205-01 | 100 CAPSULE in 1 BOTTLE (81964-205-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 250MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | No | ||||
Profile for product number 004
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 500MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | No | ||||
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