MONTELUKAST SODIUM | N020829 | ORGANON LLC A SUB OF ORGANON AND CO
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Amendment to Suitability Petition from Senores Pharmaceuticals, Inc. FDA-2025-P-1373 Senores Pharmaceuticals, Inc. filed an amendment to its ANDA suitability petition pursuant to Section 505(j)(2)(C) requesting that the FDA declare Montelukast Sodium Chewable Tablets, 10 mg suitable for submission as an abbreviated new drug application, with the reference listed drug being SINGULAIR | Suitability | 2025-06-03 | Open | Senores Pharmaceuticals |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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