DIFLUNISAL | A073562 | DASTECH INTERNATIONAL INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachmment 4 - Guidance on Diflunisal RE Suitability Petition from Pharmobed... FDA-2023-P-4280 Pharmobedient Consulting, LLC filed a petition requesting FDA guidance on the suitability of diflunisal as a reference standard for regulatory purposes. The petition seeks clarification on whether diflunisal meets the criteria for use as a reference material in pharmaceutical testing and quality con | Suitability | 2023-10-02 | Open | Pharmobedient Consulting |
Attachment 2 - DIFLUNISAL- diflunisal tablet, film coated RE Suitability Peti... FDA-2023-P-4280 Pharmobedient Consulting, LLC filed a citizen petition regarding diflunisal tablets, film coated, requesting that the FDA determine the suitability of this drug product for regulatory purposes. The petition addresses the regulatory classification and eligibility of diflunisal tablets under the appli | Suitability | 2023-10-02 | Open | Pharmobedient Consulting |
Attachment 3 - DIFLUNISAL- diflunisal orally disintegrating tablets RE Suitab... FDA-2023-P-4280 Pharmobedient Consulting, LLC filed a suitability petition requesting FDA determination that diflunisal orally disintegrating tablets are suitable for abbreviated new drug application (ANDA) review, allowing generic manufacturers to develop bioequivalent formulations of this nonsteroidal anti-inflam | Suitability | 2023-10-02 | Open | Pharmobedient Consulting |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.