FENOPROFEN CALCIUM | N017710 | DISTA PRODUCTS CO DIV ELI LILLY AND CO
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Barr Laboratories, Inc. FDA-1987-P-0132 · 4 docket documents Barr Laboratories, Inc. filed this citizen petition under Section 505(j)(2)(c) requesting permission to submit Abbreviated New Drug Applications for Fenoprofen Calcium 200 mg and 300 mg tablets for prescription use, with formulations identical to the listed drug Nalfon currently marketed by Dista in | Other | 2023-10-19 | Granted | Barr Laboratories, Inc. |
Attachment 2 Fenoprofen Calcium re Suitability Petition from Pharmobedient Co... FDA-2023-P-4417 · 6 docket documents Pharmobedient Consulting LLC filed a petition regarding the suitability of fenoprofen calcium, requesting that the FDA establish or clarify regulatory pathways and standards for this active pharmaceutical ingredient to facilitate the development and approval of generic or new drug formulations conta | Suitability | 2023-10-06 | Withdrawn | Pharmobedient Consulting LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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