Application 077857
- Type
- ANDA
- Sponsor
- SANDOZ
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 100MG/ML (100MG/ML) | No | No |
| 002 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 30MG/0.3ML (100MG/ML) | No | No |
| 003 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 40MG/0.4ML (100MG/ML) | No | No |
| 004 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 60MG/0.6ML (100MG/ML) | No | No |
| 005 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 80MG/0.8ML (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 |
|---|---|---|---|---|---|
| 0781-3133 | Enoxaparin Sodium | Enoxaparin Sodium | Sandoz Inc | ANDA | Current |
| 0781-3133 | Enoxaparin Sodium | Enoxaparin Sodium | Sandoz Inc | ANDA | Current |
| 0781-3224 | Enoxaparin Sodium | Enoxaparin Sodium | Sandoz Inc | ANDA | Current |
| 0781-3224 | Enoxaparin Sodium | Enoxaparin Sodium | Sandoz Inc | ANDA | Current |
| 0781-3238 | Enoxaparin Sodium | Enoxaparin Sodium | Sandoz Inc | ANDA | Current |
| 0781-3238 | Enoxaparin Sodium | Enoxaparin Sodium | Sandoz Inc | ANDA | Current |
| 0781-3238 | Enoxaparin Sodium | Enoxaparin Sodium | Sandoz Inc | ANDA | Current |
| 0781-3238 | Enoxaparin Sodium | Enoxaparin Sodium | Sandoz Inc | ANDA | Current |
| 0781-3246 | Enoxaparin Sodium | Enoxaparin Sodium | Sandoz Inc | ANDA | Current |
| 0781-3246 | Enoxaparin Sodium | Enoxaparin Sodium | Sandoz Inc | ANDA | Current |
| 0781-3246 | Enoxaparin Sodium | Enoxaparin Sodium | Sandoz Inc | ANDA | Current |
| 0781-3246 | Enoxaparin Sodium | Enoxaparin Sodium | Sandoz Inc | ANDA | Current |
| 0781-3256 | Enoxaparin Sodium | Enoxaparin Sodium | Sandoz Inc | ANDA | Current |
| 0781-3256 | Enoxaparin Sodium | Enoxaparin Sodium | Sandoz Inc | ANDA | Current |
| 0781-3256 | Enoxaparin Sodium | Enoxaparin Sodium | Sandoz Inc | ANDA | Current |
| 0781-3256 | Enoxaparin Sodium | Enoxaparin Sodium | Sandoz Inc | ANDA | Current |
| 0781-3262 | Enoxaparin Sodium | Enoxaparin Sodium | Sandoz Inc | ANDA | Current |
| 0781-3262 | Enoxaparin Sodium | Enoxaparin Sodium | Sandoz Inc | ANDA | Current |
| 0781-3262 | Enoxaparin Sodium | Enoxaparin Sodium | Sandoz Inc | ANDA | Current |
| 0781-3262 | Enoxaparin Sodium | Enoxaparin Sodium | Sandoz Inc | ANDA | Current |
| 0781-3268 | Enoxaparin Sodium | Enoxaparin Sodium | Sandoz Inc | ANDA | Current |
| 0781-3268 | Enoxaparin Sodium | Enoxaparin Sodium | Sandoz Inc | ANDA | Current |
| 0781-3268 | Enoxaparin Sodium | Enoxaparin Sodium | Sandoz Inc | ANDA | Current |
| 0781-3268 | Enoxaparin Sodium | Enoxaparin Sodium | Sandoz Inc | ANDA | Current |
| 0781-3298 | Enoxaparin Sodium | Enoxaparin Sodium | Sandoz Inc | ANDA | Current |
| 0781-3298 | Enoxaparin Sodium | Enoxaparin Sodium | Sandoz Inc | ANDA | Current |
| 0781-3298 | Enoxaparin Sodium | Enoxaparin Sodium | Sandoz Inc | ANDA | Current |
| 0781-3298 | Enoxaparin Sodium | Enoxaparin Sodium | Sandoz Inc | ANDA | Current |
| 0781-3299 | Enoxaparin Sodium | Enoxaparin Sodium | Sandoz Inc | ANDA | Current |
| 0781-3299 | Enoxaparin Sodium | Enoxaparin Sodium | Sandoz Inc | ANDA | Current |
| 0781-3299 | Enoxaparin Sodium | Enoxaparin Sodium | Sandoz Inc | ANDA | Current |
| 0781-3299 | Enoxaparin Sodium | Enoxaparin Sodium | Sandoz Inc | ANDA | Current |
| 0781-3356 | Enoxaparin Sodium | Enoxaparin Sodium | Sandoz Inc | ANDA | Current |
| 0781-3356 | Enoxaparin Sodium | Enoxaparin Sodium | Sandoz Inc | ANDA | Current |
| 0781-3428 | Enoxaparin Sodium | Enoxaparin Sodium | Sandoz Inc | ANDA | Current |
| 0781-3428 | Enoxaparin Sodium | Enoxaparin Sodium | Sandoz Inc | ANDA | Current |
| 0781-3500 | Enoxaparin Sodium | Enoxaparin Sodium | Sandoz Inc | ANDA | Current |
| 0781-3500 | Enoxaparin Sodium | Enoxaparin Sodium | Sandoz Inc | ANDA | Current |
| 0781-3612 | Enoxaparin Sodium | Enoxaparin Sodium | Sandoz Inc | ANDA | Current |
| 0781-3612 | Enoxaparin Sodium | Enoxaparin Sodium | Sandoz Inc | ANDA | Current |
| 0781-3655 | Enoxaparin Sodium | Enoxaparin Sodium | Sandoz Inc | ANDA | Current |
| 0781-3655 | Enoxaparin Sodium | Enoxaparin Sodium | Sandoz Inc | ANDA | Current |
| 55154-3540 | Enoxaparin Sodium | Enoxaparin Sodium | Cardinal Health | ANDA | Current |
| 55154-3541 | Enoxaparin Sodium | Enoxaparin Sodium | Cardinal Health | ANDA | Current |
| 55154-3542 | Enoxaparin Sodium | Enoxaparin Sodium | Cardinal Health | ANDA | Current |
| 55154-3543 | Enoxaparin Sodium | Enoxaparin Sodium | Cardinal Health | ANDA | Current |
| 55154-3544 | Enoxaparin Sodium | Enoxaparin Sodium | Cardinal Health | ANDA | Current |
| 55154-5441 | Enoxaparin Sodium | Enoxaparin Sodium | Cardinal Health | ANDA | Current |
| 55154-5441 | Enoxaparin Sodium | Enoxaparin Sodium | Cardinal Health | ANDA | Current |
| 55154-5441 | Enoxaparin Sodium | Enoxaparin Sodium | Cardinal Health | ANDA | Current |
| 55154-5441 | Enoxaparin Sodium | Enoxaparin Sodium | Cardinal Health | ANDA | Current |
| 55154-5442 | Enoxaparin Sodium | Enoxaparin Sodium | Cardinal Health | ANDA | Current |
| 55154-5443 | Enoxaparin Sodium | Enoxaparin Sodium | Cardinal Health | ANDA | Current |