Application 065340
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CEFPROZIL | CEFPROZIL | TABLET;ORAL | 250MG | No | No |
| 002 | CEFPROZIL | CEFPROZIL | TABLET;ORAL | 500MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16714-398 | Cefprozil | Cefprozil | NorthStar Rx LLC | ANDA | Current |
| 16714-398 | Cefprozil | Cefprozil | NorthStar Rx LLC | ANDA | Current |
| 16714-398 | Cefprozil | Cefprozil | NorthStar Rx LLC | ANDA | Current |
| 16714-399 | Cefprozil | Cefprozil | NorthStar Rx LLC | ANDA | Current |
| 16714-399 | Cefprozil | Cefprozil | NorthStar Rx LLC | ANDA | Current |
| 16714-399 | Cefprozil | Cefprozil | NorthStar Rx LLC | ANDA | Current |
| 50090-1710 | Cefprozil | Cefprozil | A-S Medication Solutions | ANDA | Current |
| 50090-1739 | Cefprozil | Cefprozil | A-S Medication Solutions | ANDA | Current |
| 50090-1739 | Cefprozil | Cefprozil | A-S Medication Solutions | ANDA | Current |
| 55700-294 | Cefprozil | Cefprozil | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-294 | Cefprozil | Cefprozil | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-294 | Cefprozil | Cefprozil | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 57237-036 | Cefprozil | Cefprozil | Rising Health, LLC | ANDA | Current |
| 57237-036 | Cefprozil | Cefprozil | Rising Health, LLC | ANDA | Current |
| 57237-036 | Cefprozil | Cefprozil | Rising Health, LLC | ANDA | Current |
| 57237-037 | Cefprozil | Cefprozil | Rising Health, LLC | ANDA | Current |
| 57237-037 | Cefprozil | Cefprozil | Rising Health, LLC | ANDA | Current |
| 57237-037 | Cefprozil | Cefprozil | Rising Health, LLC | ANDA | Current |
| 65862-068 | Cefprozil | Cefprozil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-068 | Cefprozil | Cefprozil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-068 | Cefprozil | Cefprozil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-069 | Cefprozil | Cefprozil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-069 | Cefprozil | Cefprozil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-069 | Cefprozil | Cefprozil | Aurobindo Pharma Limited | ANDA | Current |
| 67296-1180 | Cefprozil | Cefprozil | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1180 | Cefprozil | Cefprozil | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1180 | Cefprozil | Cefprozil | RedPharm Drug, Inc. | ANDA | Current |