FDA Approves Labeling for Lupin’s Meloxicam Tablets (ANDA 077944)

The FDA’s openfda record identifies an Abbreviated New Drug Application (ANDA) numbered 077944 for the non‑steroidal anti‑inflammatory drug meloxicam. The application lists Lupin Pharmaceuticals, Inc. as the manufacturer and specifies oral tablet dosage forms of 7.5 mg and 15 mg. Both tablet products are recorded with a marketing status of "Discontinued". The record includes multiple labeling submissions (submission numbers 1, 3, 8, 9, 15, 16, 19, and 21) that have received an "AP" (approved) status, with submission dates ranging from 2007 to 2024. Key identifiers include the National Drug Code (NDC) series 68180‑501 and 68180‑502, the unique ingredient identifier (UNII) VG2QF83CGL, and classification as a cyclooxygenase inhibitor under the pharmacologic class of non‑steroidal anti‑inflammatory drugs.