HYDROXYCHLOROQUINE SULFATE | A040081 | TEVA PHARMACEUTICALS USA
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from America's Frontline Doctors FDA-2025-P-1982 · 3 docket documents America's Frontline Doctors, represented by Dr. Simone Gold, filed this citizen petition on June 26, 2025, requesting that the FDA initiate rulemaking to switch hydroxychloroquine sulfate (Plaquenil and equivalent products) from prescription-only to over-the-counter status pursuant to 21 U.S.C. § 35 | Other | 2025-06-27 | Open | America's Frontline Doctors |
Citizens Petition from The America's Frontline Doctors FDA-2020-P-2066 · 4 docket documents The America's Frontline Doctors and the Association of American Physicians and Surgeons filed this citizen petition on October 12, 2020, requesting that the FDA switch hydroxychloroquine sulfate and Plaquenil from prescription to over-the-counter status pursuant to 21 U.S.C. § 353(b)(3) and 21 C.F.R | Other | 2020-10-21 | Denied | The America's Frontline Doctors |
Clinipace Worldwide - Citizen Petition FDA-2013-P-0170 · 3 docket documents 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.
Highest NADAC/Unit
$0.1545
per ea
Lowest NADAC/Unit
$0.1545
per ea
Brand NDCs
0
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00093240101HYDROXYCHLOROQUINE 200 MG TAB | $0.1545 | EA | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.