LIPITOR

FDA-2025-P-2980 · 7 docket documents

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 · 7 docket documents

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-2017-P-2967 · 7 docket documents

Lachman Consultant Services Inc filed this petition on behalf of a client requesting that the FDA declare Atorvastatin Calcium Orally Disintegrating Tablets in strengths of 10 mg, 20 mg, 40 mg, and 80 mg suitable for submission as an ANDA, with the reference-listed drug being Lipitor tablets approve

FDA-2004-P-0023 · 6 docket documents

Lachman Consultant Services, Inc. filed this petition under Section 505(j)(2)(C) requesting that the FDA determine Atorvastatin Calcium Capsules in 10 mg, 20 mg, 40 mg, and 80 mg strengths are suitable for submission in an ANDA, with Lipitor (atorvastatin calcium) Tablets 80 mg as the reference-list

FDA-2014-P-0496 · 4 docket documents

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-2011-P-0881 · 3 docket documents

The Pharmaceutical Security Institute, Inc. filed this petition on November 30, 2011, requesting that the FDA take regulatory action against BetterThanMedicare.com for promoting and selling unapproved drugs, specifically foreign versions of prescription drugs including Nexium, Lipitor, and Plavix th

FDA-2005-P-0315 · 6 docket documents

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-2001-P-0283 · 4 docket documents

Public Citizen Health Research Group filed this petition pursuant to Section 355(a)(3) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA require black box warnings and additional bolded warnings about rhabdomyolysis on all statin drug labels, including atorvastatin (Lipitor), fluva

FDA-2008-P-0085 · 5 docket documents

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