Details for New Drug Application (NDA): 050785
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NDA 050785 describes AUGMENTIN XR, which is a drug marketed by Us Antibiotics and is included in one NDA. It is available from one supplier. Additional details are available on the AUGMENTIN XR profile page.
The generic ingredient in AUGMENTIN XR 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 XR 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 050785
| Tradename: | AUGMENTIN XR |
| Applicant: | Us Antibiotics |
| Ingredient: | amoxicillin; clavulanate potassium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 050785
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AUGMENTIN XR | amoxicillin; clavulanate potassium | TABLET, EXTENDED RELEASE;ORAL | 050785 | NDA AUTHORIZED GENERIC | USAntibiotics, LLC | 81964-220 | 81964-220-28 | 28 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (81964-220-28) |
| AUGMENTIN XR | amoxicillin; clavulanate potassium | TABLET, EXTENDED RELEASE;ORAL | 050785 | NDA AUTHORIZED GENERIC | USAntibiotics, LLC | 81964-220 | 81964-220-40 | 40 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (81964-220-40) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 1GM;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Sep 25, 2002 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 050785
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Us Antibiotics | AUGMENTIN XR | amoxicillin; clavulanate potassium | TABLET, EXTENDED RELEASE;ORAL | 050785-001 | Sep 25, 2002 | 6,746,692 | ⤷ Get Started Free |
| Us Antibiotics | AUGMENTIN XR | amoxicillin; clavulanate potassium | TABLET, EXTENDED RELEASE;ORAL | 050785-001 | Sep 25, 2002 | 7,250,176 | ⤷ Get Started Free |
| Us Antibiotics | AUGMENTIN XR | amoxicillin; clavulanate potassium | TABLET, EXTENDED RELEASE;ORAL | 050785-001 | Sep 25, 2002 | 7,217,430 | ⤷ Get Started Free |
| Us Antibiotics | AUGMENTIN XR | amoxicillin; clavulanate potassium | TABLET, EXTENDED RELEASE;ORAL | 050785-001 | Sep 25, 2002 | 6,783,773 | ⤷ Get Started Free |
| Us Antibiotics | AUGMENTIN XR | amoxicillin; clavulanate potassium | TABLET, EXTENDED RELEASE;ORAL | 050785-001 | Sep 25, 2002 | 6,878,386 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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