Application 206127
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | EPTIFIBATIDE | EPTIFIBATIDE | INJECTABLE;INJECTION | 2MG/ML | No | No |
| 002 | EPTIFIBATIDE | EPTIFIBATIDE | INJECTABLE;INJECTION | 75MG/100ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 55150-218 | Eptifibatide | Eptifibatide | AuroMedics Pharma LLC | ANDA | Current |
| 55150-218 | Eptifibatide | Eptifibatide | AuroMedics Pharma LLC | ANDA | Current |
| 55150-218 | Eptifibatide | Eptifibatide | AuroMedics Pharma LLC | ANDA | Current |
| 55150-219 | Eptifibatide | Eptifibatide | AuroMedics Pharma LLC | ANDA | Current |
| 55150-219 | Eptifibatide | Eptifibatide | AuroMedics Pharma LLC | ANDA | Current |
| 55150-219 | Eptifibatide | Eptifibatide | AuroMedics Pharma LLC | ANDA | Current |
| 55150-220 | Eptifibatide | Eptifibatide | AuroMedics Pharma LLC | ANDA | Current |
| 55150-220 | Eptifibatide | Eptifibatide | AuroMedics Pharma LLC | ANDA | Current |
| 55150-220 | Eptifibatide | Eptifibatide | AuroMedics Pharma LLC | ANDA | Current |
| 59651-012 | Eptifibatide | Eptifibatide | Aurobindo Pharma Limited | ANDA | Current |
| 59651-013 | Eptifibatide | Eptifibatide | Aurobindo Pharma Limited | ANDA | Current |
| 59651-014 | Eptifibatide | Eptifibatide | Aurobindo Pharma Limited | ANDA | Current |