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 · 9 docket documents 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. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$9.21
per ea
Lowest NADAC/Unit
$9.21
per ea
Brand NDCs
2
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 78206017201SINGULAIR 10 MG TABLET | $9.21 | EA | Brand | $0.0419 | 2026-06-17 |
| 78206017202SINGULAIR 10 MG TABLET | $9.21 | EA | Brand | $0.0419 | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.