Application 204345
- Type
- ANDA
- Sponsor
- DR REDDYS LABS 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 |
|---|
| 55111-496 | capecitabine | capecitabine | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-496 | capecitabine | capecitabine | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-496 | capecitabine | capecitabine | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-497 | capecitabine | capecitabine | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-497 | capecitabine | capecitabine | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-497 | capecitabine | capecitabine | Dr. Reddy's Laboratories Limited | ANDA | Current |