FDA Approves Multiple Supplemental Applications for LIDOPEN (NDA 017549)

LIDOPEN is an injectable product containing 10% lidocaine hydrochloride (product number 001). The product was marketed as an injectable but is currently listed as discontinued. The FDA’s NDA 017549 for LIDOPEN shows a history of numerous supplemental (SUPPL) submissions spanning from the mid‑1970s to the early 2000s. The original application (ORIG) was approved on 28 March 1975 under Type 5 (new formulation or new manufacturer). Subsequent supplemental filings addressed efficacy, labeling, and manufacturing (CMC) requirements. All listed submissions carry the status "AP" (approved). Key supplemental approvals include: - Submission 3 (Efficacy) – approved 18 Oct 1976 - Submission 1 (Labeling) – approved 24 Sep 1975 - Submission 7 (Labeling) – approved 11 Jan 1978 - Multiple manufacturing (CMC) supplements (e.g., submissions 12, 14, 16, 18, 19, 20, 17) approved between 1988 and 2002. Although the product has received extensive regulatory updates, it is now discontinued, indicating it is no longer marketed.