THIOTEPA | A075547 | WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from eVenus Pharmaceutical Laboratories Inc. FDA-2015-P-1503 eVenus Pharmaceutical Laboratories Inc. filed this citizen petition under 21 CFR §10.20 and §10.30 requesting that the FDA Commissioner designate a reference listed drug for Thiotepa Injection 15mg/vial in the Orange Book and Drugs@FDA to enable future sponsors to submit abbreviated new drug applica | Other | 2015-05-12 | Denied | eVenus Pharmaceutical Laboratories Inc. |
Citizen Petition From Strides Inc. A Mylan Company FDA-2014-P-0169 Strides Inc., a Mylan company, filed this petition on January 29, 2014, requesting that the FDA declare Thiotepa for Injection USP 15mg/vial suitable for submission as an abbreviated new drug application (ANDA) under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act. The petitioner see | Other | 2014-02-18 | Withdrawn | Strides Inc. A Mylan Company |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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