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Application 203258
- Type
- ANDA
- Sponsor
- MYLAN LABS 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 |
|---|
| 67457-629 | Eptifibatide | eptifibatide | Mylan Institutional LLC | ANDA | Current |
| 67457-629 | Eptifibatide | eptifibatide | Mylan Institutional LLC | ANDA | Current |
| 67457-630 | Eptifibatide | eptifibatide | Mylan Institutional LLC | ANDA | Current |
| 67457-630 | Eptifibatide | eptifibatide | Mylan Institutional LLC | ANDA | Current |
| 67457-631 | Eptifibatide | eptifibatide | Mylan Institutional LLC | ANDA | Current |
| 67457-631 | Eptifibatide | eptifibatide | Mylan Institutional LLC | ANDA | Current |
| 72078-025 | Eptifibatide | eptifibatide | Mylan Institutional LLC | ANDA | Current |
| 72078-025 | Eptifibatide | eptifibatide | Mylan Institutional LLC | ANDA | Current |
| 72078-025 | Eptifibatide | eptifibatide | Mylan Institutional LLC | ANDA | Current |
| 72078-026 | Eptifibatide | eptifibatide | Mylan Institutional LLC | ANDA | Current |
| 72078-026 | Eptifibatide | eptifibatide | Mylan Institutional LLC | ANDA | Current |
| 72078-026 | Eptifibatide | eptifibatide | Mylan Institutional LLC | ANDA | Current |
| 72078-027 | Eptifibatide | eptifibatide | Mylan Institutional LLC | ANDA | Current |
| 72078-027 | Eptifibatide | eptifibatide | Mylan Institutional LLC | ANDA | Current |
| 72078-027 | Eptifibatide | eptifibatide | Mylan Institutional LLC | ANDA | Current |