CATAFLAM

FDA-2024-P-4134 · 11 docket documents

Pharmobedient Consulting, LLC filed this petition for reconsideration requesting FDA approval of a suitability petition to submit an ANDA for Diclofenac Potassium Tablets at 37.5 mg strength, a dose different from the Reference Listed Drug Cataflam at 25 mg and 50 mg strengths. The FDA had denied th

FDA-2023-P-4464 · 7 docket documents

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.

FDA-2023-P-4282 · 12 docket documents

Pharmobedient Consulting, LLC filed an amendment to a suitability petition submitted on October 1, 2023 for Diclofenac Potassium Orally Disintegrating Tablets in 25 mg and 50 mg strengths, providing reference listed drug labeling for CATAFLAM as requested by the FDA pursuant to 21 CFR 314.93(d).

FDA-2023-P-4444 · 7 docket documents

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.

FDA-2023-P-0174 · 6 docket documents

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

FDA-2021-P-0509 · 6 docket documents

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.

FDA-2018-P-4661 · 5 docket documents

Hyman, Phelps & McNamara, P.C. filed this citizen petition regarding Diclofenac Potassium Tablets, 50 mg, requesting that FDA designate ANDA 075219 as a new reference standard in the Orange Book because the current reference standard approved under ANDA 075463 is commercially unavailable due to manu

FDA-2003-P-0127 · 4 docket documents

The Weinberg Group, Inc. filed a suitability petition requesting that the FDA declare Diclofenac Potassium Capsules 25 mg suitable for submission as an ANDA, referencing the approved but discontinued Cataflam (diclofenac potassium) Tablets 25 mg (NDA 20-142), with the proposed product differing only