Application 078990
- Type
- ANDA
- Sponsor
- APOTEX INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 30MG/0.3ML (100MG/ML) | No | No |
| 002 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 40MG/0.4ML (100MG/ML) | No | No |
| 003 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 60MG/0.6ML (100MG/ML) | No | No |
| 004 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 80MG/0.8ML (100MG/ML) | No | No |
| 005 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 100MG/ML (100MG/ML) | No | No |
| 006 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 120MG/0.8ML (150MG/ML) | No | No |
| 007 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 150MG/ML (150MG/ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 55154-6688 | Enoxaparin Sodium | enoxaparin sodium | Cardinal Health | ANDA | Current |
| 55154-6689 | Enoxaparin Sodium | enoxaparin sodium | Cardinal Health | ANDA | Current |
| 55154-6690 | Enoxaparin Sodium | enoxaparin sodium | Cardinal Health | ANDA | Current |
| 55154-6691 | Enoxaparin Sodium | enoxaparin sodium | Cardinal Health | ANDA | Current |
| 55154-6692 | Enoxaparin Sodium | enoxaparin sodium | Cardinal Health | ANDA | Current |
| 60505-0791 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0791 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0791 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0791 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0792 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0792 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0792 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0792 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0793 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0793 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0793 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0793 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0794 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0794 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0794 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0794 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0795 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0795 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0795 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0795 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0796 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0796 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0796 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0796 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0798 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0798 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0798 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0798 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 63323-559 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-559 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-559 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-559 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-559 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-564 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-564 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-564 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-564 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-564 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-566 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-566 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-566 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-566 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-566 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-584 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-584 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-584 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-584 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-584 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-586 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-586 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-586 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-586 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-586 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-589 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-589 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-589 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-589 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-655 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-655 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-655 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-655 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |