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FDA approves Lupin Tramadol HCl ER Tablets ANDA

The US Food and Drug Administration (FDA) has approved Lupin Pharmaceuticals' Tramadol Hydrochloride Extended-Release Tablets' (Tramadol HCl ER) 100, 200 and 300 mg abbreviated new drug application (ANDA).

Tramadol HCl ER is a centrally acting synthetic analgesic in an extended release formulation.

Tramadol HCl ER is generic equivalent to Ultram ER Tablets of Ortho-McNeil-Janssen Pharmaceuticals which are used to manage moderate to moderately severe chronic pain in adults who need to be treated around the clock for their pain for an extended period of time.