AMBIEN

FDA-2025-P-2078 · 8 docket documents

Senores Pharmaceuticals, Inc. filed this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to submit an Abbreviated New Drug Application for Zolpidem Tartrate Tablet 7.5 mg, a strength that differs from the Reference Listed Drug AMBIE

FDA-2022-P-1642 · 5 docket documents

Noble Pharma, LLC filed a suitability petition requesting that the FDA determine whether brand name drug products containing zolpidem tartrate are suitable for over-the-counter marketing, seeking regulatory clarification on the feasibility of switching these prescription sleep aids to nonprescriptio

FDA-2010-P-0015 · 6 docket documents

Lachman Consultant Services, Inc. filed this citizen petition on behalf of a client under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Zolpidem Tartrate Tablets, 7.5 mg, suitable for submission as an ANDA, with Ambien Tablets 10 mg as the reference-

FDA-2009-P-0248 · 7 docket documents

Lachman Consultant Services, Inc. filed this petition on May 26, 2009 pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Zolpidem Tartrate Effervescent Tablets in 5 mg and 10 mg strengths suitable for submission as an ANDA, with Ambien zolpid

FDA-2007-P-0063 · 6 docket documents

Lachman Consultant Services, Inc. filed this petition on behalf of MonoSol Rx, LLC pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Zolpidem Tartrate Orally-Dissolving Strips in 5 mg and 10 mg strengths suitable for consideration in an abbre