LIPITOR

FDA-2025-P-2980

Premier Research Consulting, LLC filed this ANDA suitability petition requesting FDA confirmation that Atorvastatin Calcium Tablets in 15 mg, 30 mg, and 60 mg strengths are suitable for submission as a supplemental Abbreviated New Drug Application under section 505(j)(2)(C) of the Federal Food, Drug

FDA-2023-P-4281

Newcastle Bioscience, LLC filed a suitability petition regarding atorvastatin calcium orally disintegrating tablets, requesting FDA determination that the proposed drug product formulation and manufacturing process are suitable for approval under the abbreviated new drug application pathway.

FDA-2023-P-4281

Newcastle Bioscience, LLC filed a citizen petition regarding the suitability of Lipitor (atorvastatin calcium) tablets as a reference-listed drug for purposes of generic drug applications. The petition likely requested FDA evaluation or confirmation of Lipitor's appropriateness as the reference stan

FDA-2014-P-0496

Pharmacists Planning Service Inc. filed this citizen petition under 21 CFR 10.20 and 10.30 requesting that the FDA Commissioner issue a Federal Regulation to reclassify Lipitor/Atorvastatin Calcium 10 mg to allow it to be sold in both prescription and pharmacist-supervised behind-the-counter categor

FDA-2005-P-0315

Pfizer Inc. filed this citizen petition requesting that FDA carefully scrutinize and consider additional safeguards in evaluating any ANDAs for generic atorvastatin products, particularly those utilizing amorphous forms of the drug. Pfizer contends that amorphous atorvastatin polymorphs, such as For

FDA-2008-P-0085

Lupin Pharmaceuticals, Inc. filed this citizen petition on February 1, 2008, pursuant to 21 CFR 314.93 and Section 505(j)(2)(c) of the Federal Food, Drug and Cosmetic Act, requesting that the FDA declare Atorvastatin Calcium Capsules in 10 mg, 20 mg, 40 mg, and 80 mg strengths suitable for submissio