Application 091163
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FOSINOPRIL SODIUM | FOSINOPRIL SODIUM | TABLET;ORAL | 10MG | No | No |
| 002 | FOSINOPRIL SODIUM | FOSINOPRIL SODIUM | TABLET;ORAL | 20MG | No | No |
| 003 | FOSINOPRIL SODIUM | FOSINOPRIL SODIUM | TABLET;ORAL | 40MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16571-770 | Fosinopril Sodium | Fosinopril Sodium | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-771 | Fosinopril Sodium | Fosinopril Sodium | Rising Pharma Holdings, Inc. | ANDA | Current |
| 16571-772 | Fosinopril Sodium | Fosinopril Sodium | Rising Pharma Holdings, Inc. | ANDA | Current |
| 65862-471 | Fosinopril Sodium | Fosinopril Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-471 | Fosinopril Sodium | Fosinopril Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-471 | Fosinopril Sodium | Fosinopril Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-472 | Fosinopril Sodium | Fosinopril Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-472 | Fosinopril Sodium | Fosinopril Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-472 | Fosinopril Sodium | Fosinopril Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-473 | Fosinopril Sodium | Fosinopril Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-473 | Fosinopril Sodium | Fosinopril Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-473 | Fosinopril Sodium | Fosinopril Sodium | Aurobindo Pharma Limited | ANDA | Current |