Skip to contentApplication 202593
- Type
- ANDA
- Sponsor
- ACCORD HLTHCARE
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 |
|---|
| 16714-467 | CAPECITABINE | CAPECITABINE | Northstar RxLLC | ANDA | Current |
| 16714-467 | CAPECITABINE | CAPECITABINE | NORTHSTAR RXLLC | ANDA | Current |
| 16714-467 | CAPECITABINE | CAPECITABINE | NORTHSTAR RXLLC | ANDA | Current |
| 16714-467 | CAPECITABINE | CAPECITABINE | Northstar RxLLC | ANDA | Current |
| 16714-468 | CAPECITABINE | CAPECITABINE | Northstar RxLLC | ANDA | Current |
| 16714-468 | CAPECITABINE | CAPECITABINE | Northstar RxLLC | ANDA | Current |
| 16714-468 | CAPECITABINE | CAPECITABINE | NORTHSTAR RXLLC | ANDA | Current |
| 16714-468 | CAPECITABINE | CAPECITABINE | NORTHSTAR RXLLC | ANDA | Current |
| 16729-072 | CAPECITABINE | CAPECITABINE | Accord Healthcare Inc. | ANDA | Current |
| 16729-072 | CAPECITABINE | CAPECITABINE | Accord Healthcare Inc. | ANDA | Current |
| 16729-072 | CAPECITABINE | CAPECITABINE | Accord Healthcare Inc. | ANDA | Current |
| 16729-073 | CAPECITABINE | CAPECITABINE | Accord Healthcare Inc. | ANDA | Current |
| 16729-073 | CAPECITABINE | CAPECITABINE | Accord Healthcare Inc. | ANDA | Current |
| 16729-073 | CAPECITABINE | CAPECITABINE | Accord Healthcare Inc. | ANDA | Current |
| 68001-487 | CAPECITABINE | CAPECITABINE | BluePoint Laboratories | ANDA | Current |
| 68001-487 | CAPECITABINE | CAPECITABINE | BluePoint Laboratories | ANDA | Current |
| 68001-488 | CAPECITABINE | CAPECITABINE | BluePoint Laboratories | ANDA | Current |
| 68001-488 | CAPECITABINE | CAPECITABINE | BluePoint Laboratories | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 10084 | ORIG | 2015-04-27 |