CATAFLAM

FDA-2025-P-2487

Senores Pharmaceuticals, Inc. filed this suitability petition pursuant to 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 Diclofenac Potassium Tablets, 12.5 mg suitable for submission in an Abbreviated New Drug Application, with

FDA-2024-P-4134

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-2024-P-4134

Pharmobedient Consulting, LLC filed a suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 CFR 314.93 requesting that the FDA declare Diclofenac Potassium Tablets 37.5 mg suitable for submission in an Abbreviated New Drug Application. The proposed produc

FDA-2024-P-2779

Hyman, Phelps & McNamara, P.C. filed an amendment for a suitability petition regarding diclofenac potassium tablets in three strengths (12.5 mg, 25 mg, and 50 mg), which are indicated for treatment of primary dysmenorrhea, mild to moderate pain, osteoarthritis, and rheumatoid arthritis. The petition

FDA-2024-P-2779

On behalf of an unnamed client, the law firm Hyman, Phelps & McNamara filed a suitability petition under FDC Act Section 505(j)(2)(C) requesting that the FDA declare Diclofenac Potassium Tablets, 12.5 mg, suitable for submission as an ANDA, with the referenced listed drug being Novartis's CATAFLAM T

FDA-2023-P-4282

Pharmobedient Consulting, LLC filed a petition for reconsideration of the FDA's denial of its suitability petition requesting authorization to submit an ANDA for diclofenac potassium orally disintegrating tablets (25/50 mg) as a modified dosage form of the reference listed drug CAPTAFLAM. Pharmobedi

FDA-2023-P-4975

# Cannot Complete Summary I cannot provide the requested summary because the text provided does not contain the actual petition content. The material shown only includes a title and reference line indicating this is an attachment related to a suitability petition for ZIPSOR Capsules filed by Hyman,

FDA-2023-P-4975

FDA-2023-P-4464

Hyman, Phelps & McNamara, P.C. filed a suitability petition under 21 C.F.R. §314.93(b) on October 10, 2023, requesting permission to submit an Abbreviated New Drug Application for Diclofenac Potassium Tablets, 12.5 mg. The FDA determined the petition complete and established a GDUFA goal date of May

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.

FDA-2023-P-4464

Hyman, Phelps & McNamara, P.C. filed a suitability petition regarding Diclofenac Potassium Tablets, USP 12.5 mg, seeking a determination of regulatory suitability for the drug product under FDA's abbreviated new drug application (ANDA) pathway.

FDA-2023-P-4659

Hyman, Phelps & McNamara, P.C. filed a citizen petition regarding diclofenac potassium capsules, requesting a determination of suitability for ANDA approval or related regulatory action regarding the capsule formulation for this nonsteroidal anti-inflammatory drug product.

FDA-2023-P-4659

Hyman, Phelps & McNamara, P.C. filed a citizen petition regarding ZIPSOR, a liquid-filled capsule formulation of diclofenac potassium, requesting a suitability determination for the drug product as part of the regulatory approval process.

FDA-2023-P-4282

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-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.

FDA-2023-P-4444

The law firm Hyman, Phelps & McNamara, P.C., filed a suitability petition pursuant to 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 Diclofenac Potassium Tablets, 75 mg, suitable for submission as an ANDA, with the reference lis

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.

FDA-2023-P-4444

Hyman Phelps & McNamara, P.C. filed a petition requesting that the FDA issue a warning regarding the suitability of diclofenac potassium tablets. The petition seeks FDA action to communicate safety or suitability concerns related to this nonsteroidal anti-inflammatory drug product to healthcare prov

FDA-2023-P-4464

The law firm Hyman, Phelps & McNamara, P.C. 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 Diclofenac Potassium Tablets, 12.5 mg, suitable for submission as an ANDA, with the reference liste

FDA-2023-P-4282

Pharmobedient Consulting, LLC filed a suitability petition regarding diclofenac potassium, requesting that the FDA determine the suitability of this active pharmaceutical ingredient for use in drug products and establish appropriate regulatory pathways for its approval.

FDA-2023-P-4282

Pharmobedient Consulting, LLC filed a citizen petition regarding diclofenac potassium requesting that the FDA issue a warning concerning the suitability of this nonsteroidal anti-inflammatory drug. The petition focuses on warning-related actions for the diclofenac potassium product, though the speci

FDA-2023-P-4282

Pharmobedient Consulting, LLC filed a suitability petition regarding diclofenac potassium, requesting FDA guidance on the regulatory pathway and requirements for developing this drug product. The petition seeks clarification on the appropriate approval mechanism and manufacturing standards applicabl

FDA-2023-P-4282

Pharmobedient Consulting, LLC filed a suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Diclofenac Potassium Orally Disintegrating Tablets in 25 mg and 50 mg strengths suitable for submission as an Abbreviated New Drug Applica

FDA-2023-P-1988

Neuheit Pharma Technologies Pvt Ltd filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine that Levothyroxine sodium sublingual tablets in strengths of 25 mcg through 300 mcg are suitable for submission in an Abbreviat

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

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.

FDA-2023-P-0174

Hyman, Phelps & McNamara, P.C., filed this suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Diclofenac Potassium Tablets, 12.5 mg, suitable for submission as an ANDA, with Novartis Pharmaceutical Corp.'s CATAFLAM (diclof

FDA-2022-P-0052

Pharmobedient Consulting, LLC, on behalf of Amici Pharmaceuticals LLC, filed a petition requesting a suitability determination for diclofenac potassium tablets USP 50 mg to establish reference standards for regulatory purposes under an ANDA submission pathway for generic drug approval.

FDA-2022-P-0052

Pharmobedient Consulting, LLC, on behalf of Amici Pharmaceuticals LLC, filed a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to submit an ANDA for Diclofenac Potassium Orally Disintegrating Tablets in 25 mg and 50 mg strengths, wh

FDA-2022-P-0052

Pharmobedient Consulting, LLC, on behalf of Amici Pharmaceuticals LLC, filed a suitability petition regarding diclofenac potassium in November 2021. The petition sought FDA guidance on the suitability of diclofenac potassium as a drug substance for pharmaceutical development and approval.

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.

FDA-2021-P-0509

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.

FDA-2021-P-0509

Hyman, Phelps & McNamara, P.C. filed a suitability petition on behalf of a client under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that FDA declare Diclofenac Potassium Tablets, 75 mg, suitable for submission as an ANDA, with the reference listed drug being Novartis's

FDA-2018-P-4661

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

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