DIFLUNISAL | A073673 | TEVA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Pharmobedient Consulting, LLC FDA-2023-P-4280 · 11 docket documents Pharmobedient Consulting, LLC submitted a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to file an ANDA for Diflunisal Orally Disintegrating Tablets in 250 mg and 500 mg strengths, which differ in dosage form from the reference st | Suitability | 2023-10-02 | Granted | Pharmobedient Consulting, LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$1.06
per ea
Lowest NADAC/Unit
$1.06
per ea
Brand NDCs
0
Generic NDCs
3
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00093922201DIFLUNISAL 500 MG TABLET | $1.06 | EA | Generic | — | 2026-06-17 |
| 00093922205DIFLUNISAL 500 MG TABLET | $1.06 | EA | Generic | — | 2026-06-17 |
| 00093922206DIFLUNISAL 500 MG TABLET | $1.06 | EA | Generic | — | 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.