MELOXICAM | N020938 | BOEHRINGER INGELHEIM PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Pharmobedient Consulting, LLC FDA-2025-P-0343 Pharmobedient Consulting, LLC filed this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. § 314.93 requesting that the FDA declare Meloxicam Tablets in 5 mg and 10 mg strengths suitable for submission in an Abbreviated New Drug Application, wi | Suitability | 2025-01-29 | Open | Pharmobedient Consulting |
Citizen Petition from Camargo Pharmaceutical Services FDA-2005-P-0329 Camargo Pharmaceutical Services filed this citizen petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA permit the filing of an ANDA for Meloxicam Orally Disintegrating Tablets at 7.5 mg and 15 mg strengths, using Mobic (Meloxicam Tablets) as t | Other | 2015-09-30 | Denied | Camargo Pharmaceutical Services |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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