ATORVALIQ

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-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