Application 065431
- Type
- ANDA
- Sponsor
- WOCKHARDT BIO AG
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | FOR SUSPENSION;ORAL | 250MG/5ML;EQ 62.5MG BASE/5ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 60432-065 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | Morton Grove Pharmaceuticals, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8400 | ORIG | 2008-11-28 |