Elite Pharmaceuticals Inc. Announces FDA Approval of Supplemental Application for Hydromorphone
January 26, 2012 at 01:30 pm
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Elite Pharmaceuticals Inc. announced that on January 23, 2012, the U.S. Food and Drug Administration approved the company's supplemental application for the manufacturing and packaging of Hydromorphone Hydrochloride USP 8 mg. This approval will allow the company to commence the commercial manufacturing and packaging of this product for its sales and marketing partner, which will distribute the product as part of a multi-product distribution agreement. Hydromorphone hydrochloride is a member of the opioid analgesic and antitussive class. It is a pure opioid agonist used primarily for pain relief or as a cough suppressant.
Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company that develops and distributes niche generic products. The Company specializes in developing and manufacturing oral, controlled-release drug products. It owns multiple generic products which has been licensed to Prasco, LLC and TAGI Pharma. The Companyâs segments include Abbreviated New Drug Applications (ANDA) and New Drug Application (NDA). The Companyâs products include Phentermine HCl 37.5mg tablets, Loxapine Succinate 5mg, 10mg, 25mg and 50gm capsules, Phentermine HCl 15mg and 30mg capsules, Naltrexone HCl 50mg tablets, Dantrolene Sodium Capsules 25mg, 50mg and 100mg, Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Immediate Release 5mg, 7.5mg, 10mg, 12.5mg, 15mg, 20mg and 30mg tablets, Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended Release 5mg, 10mg, 15mg, 20mg, 25mg, and 30mg capsules and others.
ELITE PHARMACEUTICALS, INC. 
