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Generic Equivalent of Ultracet Granted Final Approval by FDA

DETROIT, Dec. 19 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd., (AMEX:CPD) announced today that the US Food and Drug Administration (FDA) have granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Tramadol Hydrochloride with Acetaminophen Tablets.

Caraco's Tramadol Hydrochloride (HCl) with Acetaminophen Tablets is the generic equivalent of Ortho-McNeil Pharmaceutical Inc. brand product, Ultracet(R), which is indicated for the short-term (five days or less) management of acute pain.

"We are extremely pleased on receiving this approval and plan to launch this product to the market immediately," said Daniel H. Movens, Chief Executive Officer. "This approval brings our total product portfolio to 19 different products represented by 41 strengths."

Source: Caraco Pharmaceutical Laboratories

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