AMINOSALICYLIC ACID | A074346 | ADAPTIS PHARMA PRIVATE LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Rowell Laboratories FDA-1984-P-0032 Rowell Laboratories filed a citizen petition requesting that the FDA allow 5-aminosalicylic acid suppositories to be approved through the ANDA pathway, which would enable the company to market a generic version of this medication used to treat inflammatory bowel conditions. | Other | 2014-12-29 | Denied | Rowell Laboratories |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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