Application 207864
- Type
- ANDA
- Sponsor
- HYBIO
Application Products#
| 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 | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 63739-911 | Eptifibatide | Eptifibatide Injection | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-923 | Eptifibatide | Eptifibatide Injection | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-970 | Eptifibatide | Eptifibatide Injection | McKesson Corporation dba SKY Packaging | ANDA | Current |