TOPOTECAN HYDROCHLORIDE | N020671 | SANDOZ INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Lachman Consultant Services, Inc. - Citizen Petition FDA-2012-P-0271 · 4 docket documents Lachman Consultant Services, Inc. filed this petition requesting that the FDA determine whether Topotecan Hydrochloride Intravenous Solution in three strengths (1 mg base/mL, 3 mg base/3 mL, and 4 mg base/4 mL) by Sandoz, Inc. under NDA 200-199 was voluntarily withdrawn from sale for safety or effec | 505(q) | 2012-03-26 | Denied | — |
Olsson Frank Weeda - Citizen Petition FDA-2008-P-0348 · 3 docket documents Arthur Y. Tsien of the law firm Olsson Frank Weeda filed this petition on June 12, 2008, pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to find topotecan injection, 1 mg/mL solution suitable for submission as an abbreviated new drug application ( | Other | 2008-06-18 | Withdrawn | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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