Application 209371
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | FOR SUSPENSION;ORAL | 125MG/5ML;EQ 31.25MG BASE/5ML | No | No |
| 002 | 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 59651-025 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | Aurobindo Pharma Limited | ANDA | Current |
| 59651-025 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | Aurobindo Pharma Limited | ANDA | Current |
| 59651-025 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | Aurobindo Pharma Limited | ANDA | Current |
| 59651-025 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | Aurobindo Pharma Limited | ANDA | Current |
| 59651-025 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | Aurobindo Pharma Limited | ANDA | Current |
| 59651-026 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | Aurobindo Pharma Limited | ANDA | Current |
| 59651-026 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | Aurobindo Pharma Limited | ANDA | Current |
| 59651-026 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | Aurobindo Pharma Limited | ANDA | Current |
| 59651-026 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | Aurobindo Pharma Limited | ANDA | Current |
| 59651-026 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | Aurobindo Pharma Limited | ANDA | Current |
| 69043-027 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | Cronus Pharma LLC | ANDA | Current |
| 69043-027 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | Cronus Pharma LLC | ANDA | Current |
| 69043-036 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | Cronus Pharma LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 58815 | ORIG | 2019-05-21 |