MONTELUKAST SODIUM | N020830 | 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 | Granted | Senores Pharmaceuticals, Inc. |
Suitability Petition from Senores Pharmaceuticals, Inc. FDA-2025-P-1373 Senores Pharmaceuticals, Inc. filed this petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Montelukast Sodium Chewable Tablets, 10 mg suitable for submission as an Abbreviated New Drug Application (ANDA). The petition seeks approval for a | Suitability | 2025-05-22 | Granted | Senores Pharmaceuticals, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$9.27
per ea
Lowest NADAC/Unit
$9.27
per ea
Brand NDCs
1
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 78206017301SINGULAIR 5 MG TABLET CHEW | $9.27 | EA | Brand | $0.0723 | 2026-01-01 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.