NORETHINDRONE | N016954 | JANSSEN PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Aurobindo Pharma USA Inc FDA-2022-P-0069 Aurobindo Pharma USA Inc., acting as agent for Aurobindo Pharma Limited, filed this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine whether Janssen Pharmaceuticals Inc.'s MICRONOR (Norethindrone Tablets 0.35 mg), NDA 016954, was vol | 505(q) | 2022-01-12 | Withdrawn | Aurobindo Pharma USA Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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