Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.
STAVUDINE; LAMIVUDINE; NEVIRAPINE | N022177 | STRIDES ACROLAB
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Sigmapharm Laboratories, LLC - Citizen Petition FDA-2013-P-1554 · 3 docket documents Sigmapharm Laboratories, LLC filed a citizen petition on November 26, 2013, requesting that the FDA refuse to receive any ANDA for Asenapine Maleate Sublingual Tablets that does not contain bioequivalence study results performed in accordance with the FDA's June 2013 product-specific guidance, and t | 505(q) | 2014-01-29 | Withdrawn | — |
Sigmapharm Laboratories, LLC - Citizen Petition FDA-2013-P-1623 · 4 docket documents Sigmapharm Laboratories, LLC filed this citizen petition on December 6, 2013, requesting that the FDA refuse to receive any Abbreviated New Drug Application (ANDA) for Asenapine Maleate Sublingual Tablets that does not contain results of a bioequivalence study performed in accordance with the FDA's | 505(q) | 2013-12-30 | Denied | — |
Sigmapharm Laboratories, LLC - Citizen Petition FDA-2013-P-1399 · 3 docket documents Sigmapharm Laboratories, LLC filed this citizen petition under Section 505 of the Federal Food, Drug and Cosmetic Act requesting that the FDA refuse to receive any ANDA for Asenapine Maleate Sublingual Tablets that does not contain bioequivalence study results performed in accordance with FDA's June | 505(q) | 2013-11-26 | Withdrawn | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.