ZIPSOR

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

I cannot provide the summary you requested because the document excerpt provided contains only a title and no substantive petition content. To accurately summarize the petition including the filer, drug involved, and specific requested action, I would need access to the actual petition text describi

FDA-2023-P-4975

On behalf of a client, the law firm Hyman, Phelps & McNamara, P.C. submitted a suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Diclofenac Potassium Oral Solution, 25 mg/5 mL, suitable for consideration in an ANDA, with

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. submitted a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Diclofenac Potassium Capsules, 12.5 mg, suitable for submission as an ANDA, with the reference listed drug being Assertio Therapeutics

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-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-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-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 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

I cannot provide a summary of this FDA citizen petition because the document provided contains only a title and header information without the substantive content of the petition itself. The actual text describing who filed the petition, what specific action was requested, and the rationale for the

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.