METHYLTESTOSTERONE | N003240 | NOVARTIS PHARMACEUTICALS CORP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Novitium Pharma, LLC FDA-2020-P-1605 · 3 docket documents 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A204851) as a reference standard because the previously listed reference standard TESTRED, app | 505(q) | 2020-06-23 | Withdrawn | Novitium Pharma, LLC |
Citizen Petition from ICN Pharmaceuticals, Inc. FDA-1993-P-0062 · 6 docket documents 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 | Granted | ICN Pharmaceuticals, Inc. |
Withdrawal of Approval of 128 Suitability Petitions FDA-1995-P-0005 · 13 docket documents The Food and Drug Administration is withdrawing approval of 128 suitability petitions under the Pediatric Research Equity Act of 2003, a regulatory mechanism that permits abbreviated new drug applications for drugs with different active ingredients, dosage forms, or routes of administration than the | Safety Withdrawal | 2007-03-06 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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