Application 204030
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | AMOXICILLIN | AMOXICILLIN | FOR SUSPENSION;ORAL | 125MG/5ML | No | No |
| 002 | AMOXICILLIN | AMOXICILLIN | FOR SUSPENSION;ORAL | 250MG/5ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50090-6319 | Amoxicillin | Amoxicillin | A-S Medication Solutions | ANDA | Current |
| 65862-706 | Amoxicillin | Amoxicillin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-706 | Amoxicillin | Amoxicillin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-706 | Amoxicillin | Amoxicillin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-706 | Amoxicillin | Amoxicillin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-706 | Amoxicillin | Amoxicillin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-706 | Amoxicillin | Amoxicillin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-707 | Amoxicillin | Amoxicillin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-707 | Amoxicillin | Amoxicillin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-707 | Amoxicillin | Amoxicillin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-707 | Amoxicillin | Amoxicillin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-707 | Amoxicillin | Amoxicillin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-707 | Amoxicillin | Amoxicillin | Aurobindo Pharma Limited | ANDA | Current |
| 68071-2397 | Amoxicillin | Amoxicillin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2875 | Amoxicillin | Amoxicillin | NuCare Pharmaceuticals,Inc. | ANDA | Current |