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Application 208523
- Type
- ANDA
- Sponsor
- CIPLA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | OXALIPLATIN | OXALIPLATIN | INJECTABLE;INTRAVENOUS | 50MG/10ML (5MG/ML) | No | No |
| 002 | OXALIPLATIN | OXALIPLATIN | INJECTABLE;INTRAVENOUS | 100MG/20ML (5MG/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16714-727 | oxaliplatin | oxaliplatin | NorthStar RxLLC | ANDA | Current |
| 16714-727 | oxaliplatin | oxaliplatin | NorthStar RxLLC | ANDA | Current |
| 16714-728 | oxaliplatin | oxaliplatin | NorthStar RxLLC | ANDA | Current |
| 16714-728 | oxaliplatin | oxaliplatin | NorthStar RxLLC | ANDA | Current |
| 68001-341 | oxaliplatin | oxaliplatin | BluePoint Laboratories | ANDA | Current |
| 69097-274 | oxaliplatin | oxaliplatin | Cipla USA Inc. | ANDA | Current |
| 69097-274 | oxaliplatin | oxaliplatin | Cipla USA Inc. | ANDA | Current |
| 69097-274 | oxaliplatin | oxaliplatin | Cipla USA Inc. | ANDA | Current |
| 69097-353 | oxaliplatin | oxaliplatin | Cipla USA Inc. | ANDA | Current |
| 69097-353 | oxaliplatin | oxaliplatin | Cipla USA Inc. | ANDA | Current |
| 69097-353 | oxaliplatin | oxaliplatin | Cipla USA Inc. | ANDA | Current |