Application 203820
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | REPAGLINIDE | REPAGLINIDE | TABLET;ORAL | 0.5MG | No | No |
| 002 | REPAGLINIDE | REPAGLINIDE | TABLET;ORAL | 1MG | No | No |
| 003 | REPAGLINIDE | REPAGLINIDE | TABLET;ORAL | 2MG | No | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 57237-157 | Repaglinide | Repaglinide | Rising Health, LLC | ANDA | Current |
| 57237-157 | Repaglinide | Repaglinide | Rising Health, LLC | ANDA | Current |
| 57237-157 | Repaglinide | Repaglinide | Rising Health, LLC | ANDA | Current |
| 57237-157 | Repaglinide | Repaglinide | Rising Health, LLC | ANDA | Current |
| 57237-158 | Repaglinide | Repaglinide | Rising Health, LLC | ANDA | Current |
| 57237-158 | Repaglinide | Repaglinide | Rising Health, LLC | ANDA | Current |
| 57237-158 | Repaglinide | Repaglinide | Rising Health, LLC | ANDA | Current |
| 57237-158 | Repaglinide | Repaglinide | Rising Health, LLC | ANDA | Current |
| 57237-159 | Repaglinide | Repaglinide | Rising Health, LLC | ANDA | Current |
| 57237-159 | Repaglinide | Repaglinide | Rising Health, LLC | ANDA | Current |
| 57237-159 | Repaglinide | Repaglinide | Rising Health, LLC | ANDA | Current |
| 57237-159 | Repaglinide | Repaglinide | Rising Health, LLC | ANDA | Current |
| 60687-560 | Repaglinide | Repaglinide | American Health Packaging | ANDA | Current |
| 60687-560 | Repaglinide | Repaglinide | American Health Packaging | ANDA | Current |
| 63629-8363 | Repaglinide | Repaglinide | Bryant Ranch Prepack | ANDA | Current |
| 63629-8363 | Repaglinide | Repaglinide | Bryant Ranch Prepack | ANDA | Current |
| 65862-670 | Repaglinide | Repaglinide | Aurobindo Pharma Limited | ANDA | Current |
| 65862-670 | Repaglinide | Repaglinide | Aurobindo Pharma Limited | ANDA | Current |
| 65862-670 | Repaglinide | Repaglinide | Aurobindo Pharma Limited | ANDA | Current |
| 65862-670 | Repaglinide | Repaglinide | Aurobindo Pharma Limited | ANDA | Current |
| 65862-671 | Repaglinide | Repaglinide | Aurobindo Pharma Limited | ANDA | Current |
| 65862-671 | Repaglinide | Repaglinide | Aurobindo Pharma Limited | ANDA | Current |
| 65862-671 | Repaglinide | Repaglinide | Aurobindo Pharma Limited | ANDA | Current |
| 65862-671 | Repaglinide | Repaglinide | Aurobindo Pharma Limited | ANDA | Current |
| 65862-672 | Repaglinide | Repaglinide | Aurobindo Pharma Limited | ANDA | Current |
| 65862-672 | Repaglinide | Repaglinide | Aurobindo Pharma Limited | ANDA | Current |
| 65862-672 | Repaglinide | Repaglinide | Aurobindo Pharma Limited | ANDA | Current |
| 65862-672 | Repaglinide | Repaglinide | Aurobindo Pharma Limited | ANDA | Current |