FLUORESCEIN SODIUM | N022186 | LONG GROVE PHARMACEUTICALS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Altaire Pharmaceuticals, Inc. (Lachman Consultant Services, Inc.) - Citizen P... FDA-2013-P-0493 · 3 docket documents Lachman Consultant Services, Inc., on behalf of Altaire Pharmaceuticals, Inc., filed this petition under Section 505(j) of the Federal Food, Drug and Cosmetic Act requesting that the FDA designate AK-Fluor 25% (fluorescein sodium) Injection, 250 mg/mL, NDA 022186 held by Akorn Inc., as a reference l | 505(q) | 2013-05-08 | Granted | — |
Nomax, Inc. - Citizen Petition FDA-2013-P-0505 · 4 docket documents Nomax, Inc. filed this suitability petition pursuant to 21 CFR 10.30 requesting FDA acceptance of an abbreviated new drug application (ANDA) for fluorescein sodium strips for ocular examination, citing fluorescein sodium injection as the reference listed drug, despite the proposed product differing | 505(q) | 2013-05-06 | Withdrawn | — |
Foley & Lardner LLP - Citizen Petition FDA-2011-P-0888 · 4 docket documents Foley & Lardner LLP filed this citizen petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine whether Fundescein-25, Fluorescein Sodium Injection 25% (NDA 017869, held by Novartis), was voluntarily withdrawn from sale for reasons other than | 505(q) | 2011-12-09 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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