Application 208691
- Type
- ANDA
- Sponsor
- GLENMARK PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SIROLIMUS | SIROLIMUS | TABLET;ORAL | 0.5MG | No | No |
| 002 | SIROLIMUS | SIROLIMUS | TABLET;ORAL | 1MG | No | No |
| 003 | 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 |
|---|
| 0904-7147 | sirolimus | sirolimus | Major Pharmaceuticals | ANDA | Current |
| 0904-7147 | sirolimus | sirolimus | Major Pharmaceuticals | ANDA | Current |
| 16714-187 | sirolimus | sirolimus | NORTHSTAR RX LLC | ANDA | Current |
| 16714-187 | sirolimus | sirolimus | NORTHSTAR RX LLC | ANDA | Current |
| 16714-188 | sirolimus | sirolimus | NORTHSTAR RX LLC | ANDA | Current |
| 16714-188 | sirolimus | sirolimus | NORTHSTAR RX LLC | ANDA | Current |
| 16714-189 | sirolimus | sirolimus | NORTHSTAR RX LLC | ANDA | Current |
| 16714-189 | sirolimus | sirolimus | NORTHSTAR RX LLC | ANDA | Current |
| 68462-682 | sirolimus | sirolimus | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-682 | sirolimus | sirolimus | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-683 | sirolimus | sirolimus | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-683 | sirolimus | sirolimus | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-684 | sirolimus | sirolimus | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-684 | sirolimus | sirolimus | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |