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Application 078813
- Type
- ANDA
- Sponsor
- HOSPIRA WORLDWIDE
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 |
|---|
| 61703-363 | Oxaliplatin | OXALIPLATIN | Hospira, Inc. | ANDA | Current |
| 61703-363 | Oxaliplatin | OXALIPLATIN | Hospira, Inc. | ANDA | Current |
| 61703-363 | Oxaliplatin | OXALIPLATIN | Hospira, Inc. | ANDA | Current |
| 61703-363 | Oxaliplatin | OXALIPLATIN | Hospira, Inc. | ANDA | Current |
| 61703-363 | Oxaliplatin | OXALIPLATIN | Hospira, Inc. | ANDA | Current |
| 61703-363 | Oxaliplatin | OXALIPLATIN | Hospira, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 22629 | ORIG | 2013-04-10 |