topotecan hydrochloride
topotecan hydrochloride is listed in the FDA National Drug Code directory with 3 NDC codes, marketed under brand names including topotecan hydrochloride, HYCAMTIN. Available dosage forms: injection, powder, lyophilized, for solution, powder.
Drug Details
- Generic Name
- topotecan hydrochloride
- Brand Names
- topotecan hydrochloride, HYCAMTIN
- Application Number
- ANDA202351
- Sponsor
- Accord Healthcare, Inc.
- NDC Codes
- 3
- Dosage Forms
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION, POWDER
- Routes
- INTRAVENOUS
- Active Ingredients
- TOPOTECAN HYDROCHLORIDE
Indications and Usage
1 INDICATIONS AND USAGE Topotecan hydrochloride for injection is a topoisomerase inhibitor indicated for treatment of: Patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy, as a single agent ( 1.1 ) Patients with small cell lung cancer (SCLC) platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy, as a single agent ( 1.2 ) Patients with Stage IV-B, recurrent, or persistent cervical cancer which is not amenable to curative treatment, in combination with cisplatin ( 1.3 ) 1.1 Ovarian Cancer Topotecan hydrochloride for injection, as a single agent, is indicated for the treatment of patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy. 1.2 Small Cell Lung Cancer Topotecan hydrochloride for injection, as a single agent, is indicated for the treatment of patients with small cell lung cancer (SCLC) with platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy. 1.3 Cervical Cancer Topotecan hydrochloride for injection, in combination with cisplatin, is indicated for the treatment of patients with Stage IV-B, recurrent, or persistent cervical cancer not amenable to curative treatment.