Details for New Drug Application (NDA): 091376
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The generic ingredient in TOPOTECAN HYDROCHLORIDE is topotecan hydrochloride. There are ten drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the topotecan hydrochloride profile page.
Summary for 091376
Tradename: | TOPOTECAN HYDROCHLORIDE |
Applicant: | Fresenius Kabi Usa |
Ingredient: | topotecan hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 091376
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 4MG BASE/VIAL | ||||
Approval Date: | Nov 29, 2010 | TE: | RLD: | No |
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