THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER

FDA-1984-P-0086 · 3 docket documents

Key Pharmaceuticals, Inc. filed this petition on August 20, 1984, requesting that the FDA update its list of drug products suitable for abbreviated new drug applications to include theophylline controlled-release oral tablets in a 450 mg dosage strength. The company argued that this dosage strength

FDA-2021-P-1154 · 6 docket documents

Lachman Consultant Services, Inc. filed this citizen petition requesting that the FDA determine whether THEO-DUR (theophylline) extended release tablets 300mg, NDA Number N085328, held by Schering, was voluntarily withdrawn from the commercial market for reasons of safety or efficacy. The petitioner

FDA-1986-P-0253 · 8 docket documents

G.D. Searle & Co. filed this citizen petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting permission to file an Abbreviated New Drug Application for a 400-mg strength of Theo-24 anhydrous theophylline controlled-release capsules, which would differ from the list

FDA-2017-P-6208 · 6 docket documents

INC Research/inVentiv Health filed this citizen petition on behalf of a client under 505(j)(7) requesting that the FDA determine an appropriate reference standard for conducting bioequivalence studies for Theophylline Extended Release Tablets 100mg and 200mg, since the current reference standard hol