METHYLTESTOSTERONE | A083976 | BAUSCH HEALTH US LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Novitium Pharma, LLC FDA-2020-P-1605 Novitium Pharma LLC filed this citizen petition under 21 C.F.R. § 10.30 on June 22, 2020, requesting that the FDA Commissioner designate Impax Laboratories Inc's methyltestosterone 10 mg oral capsule (ANDA A204851) as a reference standard because the previously listed reference standard TESTRED, app | 505(q) | 2020-06-23 | Withdrawn | Novitium Pharma |
Citizen Petition from ICN Pharmaceuticals, Inc. FDA-1993-P-0062 ICN Pharmaceuticals, Inc. filed this petition under 21 CFR 10.30, 25.31, and 314.93 requesting FDA approval to change the dosage form of methyltestosterone from the listed drug ORETON METHYL 25 mg tablets to allow filing of an Abbreviated New Drug Application for TESTRED 25 mg capsules, with ICN pro | Other | 2017-05-23 | Withdrawn | ICN Pharmaceuticals |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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