Topotecan is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc. The primary component is Topotecan Hydrochloride.
| Product ID | 66758-051_6bc88223-4de9-4ff7-b59f-e479c1fce600 |
| NDC | 66758-051 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Topotecan |
| Generic Name | Topotecan |
| Dosage Form | Injection |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2011-02-25 |
| Marketing Category | NDA / NDA |
| Application Number | NDA200199 |
| Labeler Name | Sandoz Inc |
| Substance Name | TOPOTECAN HYDROCHLORIDE |
| Active Ingredient Strength | 1 mg/mL |
| Pharm Classes | Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2017-12-31 |
| Marketing Start Date | 2011-02-25 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | NDA |
| Application Number | NDA200199 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2011-02-25 |
| Marketing End Date | 2011-02-25 |
| Inactivation Date | 2019-10-29 |
| Reactivation Date | 2019-11-19 |
| Marketing Category | NDA |
| Application Number | NDA200199 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2011-02-25 |
| Marketing End Date | 2011-02-25 |
| Inactivation Date | 2019-10-29 |
| Reactivation Date | 2019-11-19 |
| Marketing Category | NDA |
| Application Number | NDA200199 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2011-02-25 |
| Marketing End Date | 2011-02-25 |
| Inactivation Date | 2019-10-29 |
| Reactivation Date | 2019-11-19 |
| Ingredient | Strength |
|---|---|
| TOPOTECAN HYDROCHLORIDE | 1 mg/mL |
| SPL SET ID: | 6bc88223-4de9-4ff7-b59f-e479c1fce600 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0409-0302 | Topotecan | TOPOTECAN |
| 0703-4714 | Topotecan | Topotecan |
| 16729-243 | Topotecan | Topotecan |
| 25021-236 | topotecan | topotecan |
| 50742-404 | Topotecan | Topotecan |
| 66758-051 | Topotecan | Topotecan |
| 67457-662 | TOPOTECAN | TOPOTECAN |
| 71288-127 | Topotecan | Topotecan Hydrochloride |
| 0078-0672 | HYCAMTIN | topotecan |
| 0078-0673 | HYCAMTIN | topotecan |