Application 022160
- Type
- NDA
- Sponsor
- TEVA PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OXALIPLATIN | OXALIPLATIN | INJECTABLE;INTRAVENOUS | 50MG/10ML (5MG/ML) | Yes | Yes |
| 002 | OXALIPLATIN | OXALIPLATIN | INJECTABLE;INTRAVENOUS | 100MG/20ML (5MG/ML) | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0703-3985 | Oxaliplatin | Oxaliplatin | Teva Parenteral Medicines, Inc. | NDA | Current |
| 0703-3985 | Oxaliplatin | Oxaliplatin | Teva Parenteral Medicines, Inc. | NDA | Current |
| 0703-3985 | Oxaliplatin | Oxaliplatin | Teva Parenteral Medicines, Inc. | NDA | Current |
| 0703-3985 | Oxaliplatin | Oxaliplatin | Teva Parenteral Medicines, Inc. | NDA | Current |
| 0703-3986 | Oxaliplatin | Oxaliplatin | Teva Parenteral Medicines, Inc. | NDA | Current |
| 0703-3986 | Oxaliplatin | Oxaliplatin | Teva Parenteral Medicines, Inc. | NDA | Current |
| 0703-3986 | Oxaliplatin | Oxaliplatin | Teva Parenteral Medicines, Inc. | NDA | Current |
| 0703-3986 | Oxaliplatin | Oxaliplatin | Teva Parenteral Medicines, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 80071 | SUPPL | 2024-11-04 |
| 80066 | SUPPL | 2024-11-01 |
| 62550 | SUPPL | 2020-04-13 |
| 62545 | SUPPL | 2020-04-13 |
| 38320 | SUPPL | 2016-04-27 |
| 6988 | SUPPL | 2016-04-22 |
| 29340 | SUPPL | 2013-11-27 |
| 29339 | SUPPL | 2013-11-27 |
| 38319 | SUPPL | 2013-11-26 |
| 38318 | SUPPL | 2012-08-15 |
| 6987 | SUPPL | 2012-08-13 |
| 42434 | ORIG | 2010-05-06 |
| 24251 | ORIG | 2010-05-06 |
| 6986 | ORIG | 2009-10-13 |