HYDROXYCHLOROQUINE SULFATE | N009768 | ADVANZ PHARMA (US) CORP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Appco Pharma LLC FDA-2026-P-4374 Appco Pharma LLC filed this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting FDA approval to submit an ANDA for Hydroxychloroquine Sulfate Tablets USP 50 mg, a new strength differing from the reference listed drug PLAQUENIL Hydroxychloroquine Sulf | Suitability | 2026-04-21 | Open | Appco Pharma LLC |
Clinipace Worldwide - Citizen Petition FDA-2013-P-0170 Clinipace Worldwide filed a suitability petition under Section 505(j)(2)(C) requesting that the FDA declare new strengths of hydroxychloroquine sulfate tablets (100, 300, and 400 mg) suitable for submission of an abbreviated new drug application (ANDA), with Sanofi-Aventis's Plaquenil 200 mg (NDA 09 | Other | 2013-03-01 | Open | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.