原始来源记录
重大其他
NRXP：FDA 认定酮胺 ANDA 存在一项重大缺陷
FDA 已完成对 NRXP 无防腐剂酮胺 ANDA 的首轮审评，未发现与药物相关的缺陷。FDA 仅针对鲁尔锁式瓶口提出一项重大缺陷，要求制造商提供证明，确认该瓶与已获批的三项 ANDA 完全一致。FDA 承诺立即重新审评，并以最短周期完成。
关键事实
来源摘录
nrxp20260806_8k.htm false 0001719406 0001719406 2026-08-07 2026-08-07 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 7, 2026 NRX PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-38302 82-2844431 (State or other jurisdiction of incorporation) (Commission File Number) (I.R.S. Employer Identification Number) 1201 Orange Street, Suite 600 Wilmington , Delaware 19801 (Address of principal executive offices) (Zip Code) ( 484 ) 254-6134 (Registrant ’ s telephone number, including area code) Not applicable (Former name or former address, if changed sinc
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重大
2026年2月17日
14:21
NRXPNRX Pharmaceuticals