PALIPERIDONE | N021999 | JANSSEN PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Aurobindo Pharma USA, Inc. FDA-2024-P-2272 Aurobindo Pharma USA, Inc. filed this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine whether INVEGA (Paliperidone) Extended-Release Tablets 1.5 mg, NDA 021999, manufactured by Janssen Pharmaceuticals Inc, was withdrawn from sale fo | 505(q) | 2024-05-08 | Denied | Aurobindo Pharma USA |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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