ZOLPIDEM TARTRATE | N021412 | BIOVAIL LABORATORIES INTERNATIONAL SRL
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from LGM Pharma Solutions, LLC FDA-2026-P-1636 · 4 docket documents LGM Pharma Solutions, LLC filed this citizen petition requesting that the FDA determine whether Tovalt ODT (Zolpidem Tartrate) 5mg and 10mg tablets, approved under NDA 021412, was voluntarily withdrawn from sale for safety or efficacy reasons. The petitioner seeks this determination under 21 C.F.R. | 505(q) | 2026-02-13 | Granted | LGM Pharma Solutions, LLC |
Cover Letter RE Suitability Petition from Noble Pharma, LLC 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 | Suitability | 2022-07-21 | Granted | Noble Pharma, LLC |
Lachman Consultant Services, Inc. - Citizen Petition 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- | Other | 2010-01-11 | Denied | — |
Lachman Consultant Services, Inc. - Citizen Petition 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 | Other | 2009-06-02 | Open | — |
Citizen Petition from Lachman Consultant Services, Inc. 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Orally-Dissolving Strips in 5 mg and 10 mg strengths suitable for consideration in an abbre | Other | 2008-07-10 | Withdrawn | Lachman Consultant Services, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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