Drug
Who makes topotecan hydrochloride?
4 companies list topotecan hydrochloride as a human prescription drug, including under the names HYCAMTIN. Forms: injection, powder, lyophilized, for solution. Routes: intravenous.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing topotecan hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Novartis Pharmaceuticals CorporationSwitzerland | injection, powder, lyophilized, for solution | NDANDA020671 | 1 | 20 |
| Fresenius Kabi USA, LLCUnited States | injection, powder, lyophilized, for solution | ANDAANDA091089 | 1 | 6 |
| ACCORD HEALTHCARE LIMITEDUnited Kingdom | injection, powder, lyophilized, for solution | ANDAANDA202351 | 1 | 2 |
| Actavis LLCUnited States | injection, powder, lyophilized, for solution | ANDAANDA090620 | 1 | 1 |
Bulk ingredient listings
- ScinoPharm Taiwan, Ltd.Taiwan · 1 NDC
- ThermoFisher Scientific Cork · 1 NDC
Enquiry
Common questions
- Who makes topotecan hydrochloride?
- 4 companies list topotecan hydrochloride as a human prescription drug in the openFDA NDC Directory, led by Novartis Pharmaceuticals Corporation, Fresenius Kabi USA, LLC, ACCORD HEALTHCARE LIMITED, Actavis LLC. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic HYCAMTIN?
- 3 companies list topotecan hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies topotecan hydrochloride active ingredient?
- 2 companies list topotecan hydrochloride as a bulk ingredient, including ScinoPharm Taiwan, Ltd., ThermoFisher Scientific Cork.