Active ingredient
Topotecan
8 finished FDA listings contain Topotecan as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- TOPOTECAN, TOPOTECAN HYDROCHLORIDE
- Dosage forms
- Capsule, Injection, Injection, Powder, Lyophilized, For Solution, Injection, Solution, Concentrate
- Routes
- Intravenous, Oral
- Manufacturers / labelers
- 7
- Strengths listed
- .25 mg/1 · 1 mg/1 · 1 mg/ml · 4 mg/4ml
- Brand names in FDA listings
- Hycamtin
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 57308
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 020671 | SANDOZ | 1996-05-28 | 1 |
| NDA 020981 | SANDOZ | 2007-10-11 | 2 |
| ANDA 091089 | FRESENIUS KABI USA | 2010-11-29 | 1 |
| ANDA 090620 | ACTAVIS TOTOWA | 2010-12-02 | 1 |
| NDA 200582 | HOSPIRA INC | 2011-02-02 | 1 |
| ANDA 202351 | ACCORD HLTHCARE | 2013-06-26 | 1 |
| ANDA 204406 | ACCORD HLTHCARE | 2017-07-06 | 1 |
Official labeling on DailyMed
- TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] · version 15 · 2026-02-09
- TOPOTECAN INJECTION [ACCORD HEALTHCARE INC.] · version 8 · 2025-12-19
- HYCAMTIN (TOPOTECAN) CAPSULE [SANDOZ INC] · version 1 · 2024-10-31
- TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACCORD HEALTHCARE, INC.] · version 10 · 2024-10-07
- TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTAVIS PHARMA, INC.] · version 10 · 2022-11-22
- HYCAMTIN (TOPOTECAN HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] · version 8 · 2022-07-11
- TOPOTECAN INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.] · version 23 · 2021-02-03
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.