Application 091316
- Type
- ANDA
- Sponsor
- DR REDDYS LABS 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 |
|---|
| 43598-606 | Fondaparinux Sodium | Fondaparinux Sodium | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-606 | Fondaparinux Sodium | Fondaparinux Sodium | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-606 | Fondaparinux Sodium | Fondaparinux Sodium | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-607 | Fondaparinux Sodium | Fondaparinux Sodium | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-607 | Fondaparinux Sodium | Fondaparinux Sodium | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-607 | Fondaparinux Sodium | Fondaparinux Sodium | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-608 | Fondaparinux Sodium | Fondaparinux Sodium | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-608 | Fondaparinux Sodium | Fondaparinux Sodium | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-608 | Fondaparinux Sodium | Fondaparinux Sodium | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-609 | Fondaparinux Sodium | Fondaparinux Sodium | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-609 | Fondaparinux Sodium | Fondaparinux Sodium | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-609 | Fondaparinux Sodium | Fondaparinux Sodium | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 55111-678 | Fondaparinux Sodium | Fondaparinux Sodium | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-678 | Fondaparinux Sodium | Fondaparinux Sodium | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-678 | Fondaparinux Sodium | Fondaparinux Sodium | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-678 | Fondaparinux Sodium | Fondaparinux Sodium | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-679 | Fondaparinux Sodium | Fondaparinux Sodium | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-679 | Fondaparinux Sodium | Fondaparinux Sodium | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-679 | Fondaparinux Sodium | Fondaparinux Sodium | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-679 | Fondaparinux Sodium | Fondaparinux Sodium | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-680 | Fondaparinux Sodium | Fondaparinux Sodium | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-680 | Fondaparinux Sodium | Fondaparinux Sodium | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-680 | Fondaparinux Sodium | Fondaparinux Sodium | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-680 | Fondaparinux Sodium | Fondaparinux Sodium | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-681 | Fondaparinux Sodium | Fondaparinux Sodium | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-681 | Fondaparinux Sodium | Fondaparinux Sodium | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-681 | Fondaparinux Sodium | Fondaparinux Sodium | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-681 | Fondaparinux Sodium | Fondaparinux Sodium | Dr. Reddy's Laboratories Limited | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 31524 | ORIG | 2011-07-28 |