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Article: Company files ANDA for tramadol hydrochloride tablets with acetaminophen.
- Article from:
- Biotech Week
- Article date:
- December 18, 2002
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2002 DEC 18 - (NewsRx.com & NewsRx.net) -- Par Pharmaceutical, Inc., a subsidiary of Pharmaceutical Resources, Inc., (PRX), announced that through its alliance partner Kali Laboratories, Inc., an abbreviated new drug application (ANDA) was filed with a paragraph IV certification for tramadol hydrochloride tablets with acetaminophen.
Johnson and Johnson currently markets 37.5 mg tramadol HCl/325 mg acetaminophen tablets under the brand name Ultracet. Introduced in September 2001, Ultracet is indicated for the short-term (5 or fewer days) management of acute pain. The product achieved U.S. sales of more than $40 million in the second quarter of 2002.
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