LEVOLET

FDA-2023-P-5654

VRT Pharma Consulting LLC, on behalf of Neuheit Pharma Technologies Private Ltd, filed an amendment to a suitability petition seeking FDA permission to submit an ANDA for levothyroxine sodium sublingual tablets in 12 strengths ranging from 25 mcg to 300 mcg as a change in route of administration fro

FDA-2023-P-1988

Neuheit Pharma Technologies Pvt Ltd filed a suitability petition regarding labeling for SYNTHROID (levothyroxine sodium) tablets, seeking FDA review and approval of proposed labeling changes for this levothyroxine sodium product.

FDA-2023-P-1988

Neuheit Pharma Technologies Pvt Ltd filed a petition regarding levothyroxine sodium, submitting a reference paper by Skelin and colleagues examining factors affecting gastrointestinal absorption of this thyroid hormone replacement therapy to support arguments related to regulatory equivalence suitab

FDA-2023-P-1988

Neuheit Pharma Technologies Pvt Ltd filed a petition requesting FDA guidance on bioequivalence study design and suitability requirements for developing generic levothyroxine sodium tablets. The petition seeks clarification on the appropriate regulatory pathway and bioequivalence standards for this n

FDA-2021-P-1175

Felix Pharmaceuticals Pvt. Ltd. submitted this petition under Section 512(n)(3) of the Federal Food, Drug and Cosmetic Act requesting permission to file an abbreviated new animal drug application (ANADA) for a generic levothyroxine sodium oral solution for dogs, which would differ from the approved

FDA-1997-N-0041

Knoll Pharmaceutical Company submitted this citizen petition on December 15, 1997, requesting that the FDA Commissioner determine that Synthroid, an orally administered levothyroxine sodium product, is generally recognized as safe and effective under section 201(p) of the Food, Drug, and Cosmetic Ac

FDA-1997-N-0041

Jerome Stevens Pharmaceuticals Inc., represented by Reed Smith LLP, filed this citizen petition requesting that the FDA refuse to extend the August 14, 2001 deadline for manufacturers of orally administered levothyroxine sodium drug products to obtain approved new drug applications (NDAs). JSP argue

FDA-1997-N-0041

Mason, Taylor & Colicchio, a law firm representing a pharmaceutical manufacturer, filed this citizen petition requesting that the FDA rescind its August 14, 1997 determination that oral levothyroxine sodium products are "new drugs" requiring NDA approval under Federal Food, Drug, and Cosmetic Act se