OXAPROZIN | A075842 | AARXION ANDA HOLDING LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 4 Draft Guidance Oxaprozin re Suitability Petition from Pharmobedi... FDA-2023-P-4290 Pharmobedient Consulting LLC filed a suitability petition regarding oxaprozin, requesting FDA guidance on the suitability of the drug substance for use in pharmaceutical formulations and requesting that the agency issue a determination regarding the appropriate regulatory pathway and standards for o | Suitability | 2023-10-03 | Open | Pharmobedient Consulting LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.