CATAFLAM

FDA-2025-P-2487 · 10 docket documents

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 · 11 docket documents

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 · 12 docket documents

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-4975 · 8 docket documents

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FDA-2023-P-4659 · 7 docket documents

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-4464 · 7 docket documents

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-4444 · 7 docket documents

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-4282 · 12 docket documents

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 · 10 docket documents

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 · 6 docket documents

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 · 9 docket documents

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-2021-P-0509 · 6 docket documents

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 · 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