NEXIUM

FDA-2019-P-5691 · 6 docket documents

Foley & Lardner LLP filed this ANDA suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA Commissioner determine that an Abbreviated New Drug Application may be submitted for esomeprazole magnesium delayed-release capsules in 2.5 mg, 5 mg

FDA-2012-P-0661 · 4 docket documents

Sandoz, Inc. filed this petition requesting that the FDA issue a written decision holding that the first applicant to submit a Paragraph IV ANDA for a generic version of NEXIUM (esomeprazole magnesium) Delayed Release Capsules has forfeited its 180-day exclusivity rights under 21 U.S.C. § 355(j)(5)(

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-2011-P-0741 · 4 docket documents

Public Citizen's Health Research Group filed this citizen petition pursuant to 21 U.S.C. § 352 and 21 C.F.R. §§ 10.30 and 201.56 requesting that the FDA immediately add black box warnings and other enhanced safety labeling to all proton pump inhibitors including Nexium, Dexilant, Prilosec, Zegerid,

FDA-2008-P-0080 · 6 docket documents

Lupin Pharmaceuticals, Inc. filed this suitability petition pursuant to 21 CFR 314.93 and Section 505(j)(2)(c) of the Federal Food, Drug and Cosmetic Act requesting FDA approval to submit an abbreviated new drug application for Esomeprazole Delayed-Release Tablets in 20 mg and 40 mg strengths, which