DICLOFENAC POTASSIUM | A076561 | AMICI PHARMA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 2 - CATAFLAM (diclofenac potassium immediate-release tablets)
Tabl... FDA-2023-P-4464 Hyman, Phelps & McNamara, P.C. filed a suitability petition regarding CATAFLAM (diclofenac potassium immediate-release tablets) 50 mg, seeking FDA determination on the suitability of the product for abbreviated new drug application (ANDA) review and approval. | Suitability | 2023-10-30 | Open | Hyman |
Attachment 5 -RLD CATAFLAM Labeling RE: Suitability Petition Amendment from P... FDA-2023-P-4282 Pharmobedient Consulting filed a suitability petition amendment regarding the reference listed drug Cataflam and its labeling. The specific requested action and regulatory mechanism are not detailed in the provided text excerpt. | Suitability | 2023-10-18 | Open | — |
Attachment 2 Prescribing Information for CATAFLAM re Suitability Petition fro... FDA-2023-P-4444 Hyman, Phelps & McNamara, P.C. filed a petition regarding the prescribing information for CATAFLAM, a nonsteroidal anti-inflammatory drug. The petition addresses suitability matters related to the product's labeling and prescribing information requirements. | Suitability | 2023-10-11 | Open | Hyman |
Attachment 2 Approved labeling for CATAFLAM Tablets re Suitability Petition f... FDA-2023-P-0174 Hyman Phelps and McNamara PC filed a citizen petition regarding the suitability of approved labeling for CATAFLAM Tablets, a diclofenac product. The petition sought FDA review and action concerning the adequacy and appropriateness of the existing product labeling under FDA regulatory authority. | Suitability | 2023-01-18 | Open | Hyman Phelps and McNamara PC |
Attachment 1 Current Orange Book entry for CATAFLAM Tablets, 25 mg and 50 mg ... FDA-2023-P-0174 Hyman Phelps and McNamara PC filed a petition requesting that the FDA reconsider the Orange Book suitability status of CATAFLAM tablets in 25 mg and 50 mg strengths. The petition challenges the current regulatory classification of these diclofenac potassium products to determine whether they remain | Suitability | 2023-01-18 | Open | Hyman Phelps and McNamara PC |
Attachment 1 - CATAFLAM - Discontinued Drug Product List RE Suitability Petit... FDA-2021-P-0509 Hyman, Phelps & McNamara, P.C. filed a suitability petition regarding Cataflam, requesting that the FDA consider the drug's inclusion on the Discontinued Drug Product List or make a determination regarding its regulatory status and suitability for continued marketing or approval of generic versions. | Suitability | 2021-05-26 | Open | Hyman |
Attachment 2 - CATAFLAM PI (diclofenac potassium immediate-release tablets) R... FDA-2021-P-0509 Hyman, Phelps & McNamara, P.C. filed a suitability petition regarding Cataflam (diclofenac potassium immediate-release tablets), requesting that the FDA determine the suitability of the product's prescribing information for use as a reference standard in evaluating generic drug applications. | Suitability | 2021-05-26 | Open | Hyman |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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