METHOCARBAMOL | N011011 | ENDO OPERATIONS LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Granules India Limited FDA-2023-P-0576 · 2 docket documents Granules India Limited submitted this suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting FDA approval to file an ANDA for Methocarbamol Capsules in 500 mg and 750 mg strengths, which would differ from the reference listed drug Robaxin Methocar | Suitability | 2023-02-21 | Open | Granules India Limited |
Citizen Petition from Lachman Consultant Services, Inc. FDA-2006-P-0150 · 5 docket documents Lachman Consultant Services, Inc., filed this citizen petition on behalf of a client pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act, requesting that the FDA declare Methocarbamol Tablets USP 1000 mg suitable for submission as an ANDA, with Robaxin-750 Tablets (NDA 11-011 | Other | 2008-05-06 | Granted | Lachman Consultant Services, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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