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#Lidocaine ×

UPDATED
規制動向
2026年9月24日•1分で読めます
FDA Approves ANDA217117 for LIDOCAINE Topical Ointment
The FDA has approved Aurobindo Pharma's LIDOCAINE 5% topical ointment (ANDA217117) for prescription use, with a standard review completed on June 18, 2024.
UPDATED
規制動向
2026年9月23日•1分で読めます
FDA Approves Lidocaine Hydrochloride Injection (NDA 017584)
The FDA has approved preservative‑free lidocaine hydrochloride injectable products (2% and 4%) under NDA 017584, manufactured by Fresenius Kabi USA.
UPDATED
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2026年9月23日•1分で読めます
FDA Approves Multiple Supplemental Applications for LIDOPEN (NDA 017549)
The FDA has granted approval for several supplemental submissions related to LIDOPEN, an injectable lidocaine product now discontinued.
UPDATED
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2026年9月9日•1分で読めます
FDA Approves Multiple Submissions for Lidocaine Hydrochloride Injection (Discontinued Product)
The FDA has approved several labeling and manufacturing submissions for the discontinued injectable lidocaine hydrochloride (2%) product.
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UPDATED
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2026年8月31日•1分で読めます
FDA Approves ANDA083389 for Lidocaine Hydrochloride with Epinephrine Injection (Discontinued)
The FDA approved ANDA083389 for a lidocaine hydrochloride 1% injection containing 0.01 mg/mL epinephrine, submitted by Dell Labs; the product is listed as discontinued.
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UPDATED
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2026年8月30日•1分で読めます
FDA Approves Manufacturing Submissions for XYLOCAINE Ointment (NDA 008048)
The FDA record for NDA 008048 shows XYLOCAINE ointment, a discontinued 5% lidocaine topical, received multiple approved manufacturing and labeling submissions from 1984 to 1996.
UPDATED
規制動向
2026年8月24日•1分で読めます
FDA Approves LIDOCAINE AND PRILOCAINE Topical Cream (ANDA076320)
The FDA approved ANDA076320 for a prescription topical cream containing 2.5% lidocaine and 2.5% prilocaine, manufactured by Encube Ethicals.
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