HYDROXYUREA | N016295 | WAYLIS THERAPEUTICS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from McKenna & Cuneo LLP FDA-1998-P-1134 McKenna & Cuneo LLP, on behalf of a pharmaceutical client, submitted this petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting authorization to file an abbreviated new drug application (ANDA) for a hydroxyurea scored tablet 1000 mg product, which would differ fr | Other | 2017-04-12 | Granted | McKenna & Cuneo LLP |
Citizen Petition from Duramed Pharmaceuticals, Inc. FDA-1996-P-0107 Duramed Pharmaceuticals, Inc. submitted this petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA permit acceptance of an Abbreviated New Drug Application for a 250 mg capsule strength of Hydroxyurea Capsules and amend the suitability list to include | Other | 2009-06-10 | Open | Duramed Pharmaceuticals, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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