Regulatory Updates
Sep 24, 2026•1 min read
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.
Regulatory Updates
Sep 23, 2026•1 min read
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.
Regulatory Updates
Sep 23, 2026•1 min read
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.
Regulatory Updates
Sep 9, 2026•1 min read
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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Regulatory Updates
Aug 31, 2026•1 min read
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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Regulatory Updates
Aug 30, 2026•1 min read
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.
Regulatory Updates
Aug 24, 2026•1 min read
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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