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Home » FDA approves Lupin’s UltramR ER

FDA approves Lupin’s UltramR ER

August 31, 2011
CenterWatch Staff

Lupin Pharmaceuticals has received final approval from the FDA for its Abbreviated New Drug Application (ANDA) for Tramadol Hydrochloride Extended-Release Tablets, 100, 200 and 300 mg strengths. Lupin will begin shipping its Tramadol ERshortly.

Tramadol HCl ER is a centrally acting synthetic analgesic in an extended release formulation.  It is the generic equivalent to Ortho-McNeil's UltramR ER Tablets and is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.

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