RIZATRIPTAN BENZOATE | N020864 | ORGANON LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Newcastle Bioscience LLC FDA-2025-P-1465 · 22 docket documents Newcastle Bioscience LLC filed this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Rizatriptan Benzoate Tablets 7.5 mg suitable for submission as an abbreviated new drug application, with Maxalt (Rizatriptan Benzoate) Tablets 1 | Suitability | 2025-05-30 | Denied | Newcastle Bioscience LLC |
Citizen Petition from IntelGenx Corporation FDA-2013-P-1058 · 4 docket documents IntelGenx Corporation filed this citizen petition in August 2013 requesting that the FDA designate Rizatriptan Oral Film as therapeutically equivalent (AB) to the reference listed drug Maxalt-MLT (rizatriptan benzoate orally disintegrating tablet, NDA 20-865) under section 505(b)(2) of the Federal F | 505(q) | 2013-09-16 | Withdrawn | IntelGenx Corporation |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$44.48
per ea
Lowest NADAC/Unit
$44.48
per ea
Brand NDCs
1
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 78206014201MAXALT 10 MG TABLET | $44.48 | EA | Brand | $0.3895 | 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.