ETODOLAC | N018922 | WYETH PHARMACEUTICALS INC
| 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 |
Suitability Petition from Pharmobedient Consulting FDA-2023-P-4877 Pharmobedient Consulting, LLC filed this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. § 314.93 requesting that the FDA declare Etodolac Tablets in 200 mg and 250 mg strengths suitable for submission in an Abbreviated New Drug Application, | 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 |
Attachment 1 - Orange book - Lodine Tablet-3 re: Suitability Petition from Ph... FDA-2023-P-4877 Pharmobedient Consulting filed a citizen petition regarding Lodine tablets, requesting a determination on the suitability of the drug product for inclusion in the Orange Book and its availability for generic drug development through abbreviated new drug application (ANDA) pathways. | Suitability | 2023-11-03 | Open | Pharmobedient Consulting |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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