Application 207456
- Type
- ANDA
- Sponsor
- SHILPA MEDICARE LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CAPECITABINE | CAPECITABINE | TABLET;ORAL | 150MG | No | No |
| 002 | CAPECITABINE | CAPECITABINE | TABLET;ORAL | 500MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 59923-721 | Capecitabine | Capecitabine | Areva Pharmaceuticals | ANDA | Current |
| 59923-721 | Capecitabine | Capecitabine | Areva Pharmaceuticals | ANDA | Current |
| 59923-722 | Capecitabine | Capecitabine | Areva Pharmaceuticals | ANDA | Current |
| 59923-722 | Capecitabine | Capecitabine | Areva Pharmaceuticals | ANDA | Current |
| 63759-3000 | Capecitabine | Capecitabine | Shilpa Medicare Limited | ANDA | Current |
| 63759-3001 | Capecitabine | Capecitabine | Shilpa Medicare Limited | ANDA | Current |
| 64980-276 | Capecitabine | Capecitabine | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 64980-277 | Capecitabine | Capecitabine | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 72485-204 | Capecitabine 150mg | Capecitabine | Armas Pharmaceuticals Inc. | ANDA | Current |
| 72485-204 | Capecitabine 150mg | Capecitabine | Armas Pharmaceuticals Inc. | ANDA | Current |
| 72485-205 | Capecitabine 500mg | Capecitabine | Armas Pharmaceuticals Inc. | ANDA | Current |
| 72485-205 | Capecitabine 500mg | Capecitabine | Armas Pharmaceuticals Inc. | ANDA | Current |
| 72606-554 | Capecitabine 150mg | Capecitabine | CELLTRION USA, INC. | ANDA | Current |
| 72606-555 | Capecitabine 500mg | CAPECITABINE | CELLTRION USA, INC. | ANDA | Current |