行业洞察美国 FDAT1064
SpecGx LLC; Withdrawal of Approval of Abbreviated New Drug Application for Methylphenidate Hydrochloride Extended-Release Tablets, 27 Milligrams, 36 Milligrams, and 54 Milligrams
🤖 AI 摘要
The Food and Drug Administration (FDA or Agency) is withdrawing approval of abbreviated new drug application (ANDA) 202608 for Methylphenidate Hydrochloride (HCl) Extended-Release (ER) tablets, 27 milligrams (mg), 36 mg, and 54 mg, held by SpecGx LLC (SpecGx), 385 Marshall Ave., Webster Groves, MO 63119. SpecGx requested withdrawal of approval of this application and has waived its opportunity for a hearing.
分析模型：rule-based-v3 · 07-09 06:59
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综合分 64/100
信源权威
95
影响范围
70
时效性
50
合规紧急
40
行业关注
35
Federal Register: FDA Notices (官方通知)
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