ETODOLAC | A074819 | OXFORD PHARMACEUTICALS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 4 -Etodolac PI Revision -re: Suitability Petition from Pharmobedie... FDA-2023-P-4877 Pharmobedient Consulting filed a petition regarding the suitability of etodolac, seeking revisions to the product information for this nonsteroidal anti-inflammatory drug. The specific regulatory mechanism and detailed requested action are not explicitly stated in the provided text excerpt. | Suitability | 2023-11-03 | Open | Pharmobedient Consulting |
Attachment 5 -ETODOLAC TABLETS USP- re: Suitability Petition from Pharmobedie... FDA-2023-P-4877 Pharmobedient Consulting filed a petition regarding etodolac tablets USP, requesting that the FDA determine the suitability of this drug substance and formulation for use in abbreviated new drug applications (ANDAs) to facilitate generic drug development and approval. | Suitability | 2023-11-03 | Open | Pharmobedient Consulting |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.