METAXALONE | A040445 | SANDOZ INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Mutual Pharmaceutical Company, Inc. FDA-2001-P-0001 · 4 docket documents Mutual Pharmaceutical Company, Inc. filed this citizen petition on March 6, 2001, requesting that the FDA withhold approval of any abbreviated new drug application (ANDA) for generic metaxalone tablets (Skelaxin, 400 mg) unless accompanied by an acceptable in-vivo fasting bioequivalence study, and f | 505(q) | 2012-04-25 | Granted | — |
Mutual Pharmaceutical Company, Inc. - Citizen Petition FDA-2009-P-0223 · 6 docket documents Mutual Pharmaceutical Company, Inc. filed this citizen petition under 21 CFR §10.30 requesting that the FDA declare Skelaxin (metaxalone) 800 mg tablets misbranded and require King Pharmaceuticals to update its NDA labeling to reflect that Skelaxin is a delayed release dosage form, update the dosage | 505(q) | 2009-05-18 | Denied | — |
Mutual Pharmaceutical Company - Citizen Petition FDA-2007-P-0017 · 7 docket documents Mutual Pharmaceutical Company filed this citizen petition on July 27, 2007, requesting that the FDA require labeling changes for Skelaxin (metaxalone) to include information about the drug's metabolism by specific P450 liver enzymes (CYP1A2, CYP2D6, CYP2E1, and CYP3A4) and potential interactions wit | 505(q) | 2008-06-19 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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