AMPHETAMINE

FDA-2022-P-0509 · 8 docket documents

Arnall Golden Gregory LLP filed this citizen petition requesting that the FDA establish new science-based regulatory limits to control the impurity 2-methyl-3-phenylaziridine in amphetamine salts active pharmaceutical ingredients used in ADHD medications such as Adderall and Dexedrine. The petitione

FDA-2014-P-1038 · 6 docket documents

Lachman Consultant Services Inc. filed a petition requesting that the FDA determine Amphetamine Sulfate Tablets USP in strengths of 2.5 mg, 15 mg, 20 mg, and 30 mg are suitable for submission as an ANDA. The FDA acknowledged receipt of the petition and assigned it docket number FDA-2014-P-1038 on Se

FDA-2005-P-0120 · 26 docket documents

Shire Pharmaceuticals Group filed this citizen petition on October 2, 2005, requesting that the FDA establish more stringent bioequivalence requirements for generic and follow-on drug products referencing Adderall XL (mixed amphetamine salts extended-release capsules). Shire petitioned that applican

FDA-2010-P-0188 · 17 docket documents

Actavis Elizabeth LLC submitted this citizen petition on April 6, 2010, pursuant to 21 C.F.R. § 10.30 and Section 505(q) of the Federal Food, Drug and Cosmetic Act, requesting that the FDA deem U.S. Patent No. RE41,148 (a reissued amphetamine combination extended-release capsule patent for Adderall

FDA-2009-P-0273 · 5 docket documents

Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA determine whether Amphetamine Sulfate 5 mg and 10 mg Tablets (NDA 83-901 Products 001 and 002) held by Lannett Company, Inc. was voluntarily withdrawn or withheld from sale for reasons of safety or ef