TECHNETIUM TC-99M MEDRONATE KIT | N018124 | SUN PHARMACEUTICAL INDUSTRIES INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Pharmalucence, Inc. FDA-2018-P-2175 Pharmalucence, Inc. filed this citizen petition in June 2018 requesting that the FDA establish therapeutic equivalence between Technetium TC-99m Medronate Kit (Pharmalucence CIS-MDP NDA 018124) and Technetium TC-99m Medronate (DRAXIMAGE MDP-25 NDA 018035) under the Orange Book pursuant to 21 CFR 10. | Other | 2018-06-07 | Withdrawn | Pharmalucence |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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