Application 201578
- Type
- ANDA
- Sponsor
- DR REDDYS LABS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SIROLIMUS | SIROLIMUS | TABLET;ORAL | 1MG | No | No |
| 002 | SIROLIMUS | SIROLIMUS | TABLET;ORAL | 2MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50268-718 | Sirolimus | Sirolimus | AvPAK | ANDA | Current |
| 50268-718 | Sirolimus | Sirolimus | AvPAK | ANDA | Current |
| 55111-653 | Sirolimus | Sirolimus | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-653 | Sirolimus | Sirolimus | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-653 | Sirolimus | Sirolimus | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-653 | Sirolimus | Sirolimus | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-654 | Sirolimus | Sirolimus | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-654 | Sirolimus | Sirolimus | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-654 | Sirolimus | Sirolimus | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-654 | Sirolimus | Sirolimus | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 68084-915 | Sirolimus | Sirolimus | American Health Packaging | ANDA | Current |
| 68084-915 | Sirolimus | Sirolimus | American Health Packaging | ANDA | Current |
| 68084-915 | Sirolimus | Sirolimus | American Health Packaging | ANDA | Current |
| 68084-915 | Sirolimus | Sirolimus | American Health Packaging | ANDA | Current |