Application 206918
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | INJECTABLE;SUBCUTANEOUS | 2.5MG/0.5ML | No | No |
| 002 | FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | INJECTABLE;SUBCUTANEOUS | 5MG/0.4ML | No | No |
| 003 | FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | INJECTABLE;SUBCUTANEOUS | 7.5MG/0.6ML | No | No |
| 004 | FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | INJECTABLE;SUBCUTANEOUS | 10MG/0.8ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 55150-230 | FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | AuroMedics Pharma LLC | ANDA | Current |
| 55150-230 | FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | AuroMedics Pharma LLC | ANDA | Current |
| 55150-230 | FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | AuroMedics Pharma LLC | ANDA | Current |
| 55150-230 | FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | AuroMedics Pharma LLC | ANDA | Current |
| 55150-231 | FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | AuroMedics Pharma LLC | ANDA | Current |
| 55150-231 | FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | AuroMedics Pharma LLC | ANDA | Current |
| 55150-231 | FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | AuroMedics Pharma LLC | ANDA | Current |
| 55150-231 | FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | AuroMedics Pharma LLC | ANDA | Current |
| 55150-232 | FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | AuroMedics Pharma LLC | ANDA | Current |
| 55150-232 | FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | AuroMedics Pharma LLC | ANDA | Current |
| 55150-232 | FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | AuroMedics Pharma LLC | ANDA | Current |
| 55150-232 | FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | AuroMedics Pharma LLC | ANDA | Current |
| 55150-233 | FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | AuroMedics Pharma LLC | ANDA | Current |
| 55150-233 | FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | AuroMedics Pharma LLC | ANDA | Current |
| 55150-233 | FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | AuroMedics Pharma LLC | ANDA | Current |
| 55150-233 | FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | AuroMedics Pharma LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 50969 | ORIG | 2017-12-29 |