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Par Pharmaceutical Companies, Inc. announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for the 100mg and 200mg strengths of tramadol ER. Ortho–McNeil sells extended–release tramadol tablets under the brand name Ultram ER. Par has been awarded 180 days of marketing exclusivity, commencing at launch, for being the first to file an ANDA containing a paragraph IV certification for the product.


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