Elite Pharmaceuticals and SunGen Pharma File ANDA for an Antibiotic
January 03, 2019 at 06:00 pm IST
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Elite Pharmaceuticals, Inc. announced that it filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for a generic version of an antibiotic product. This is the third ANDA that Elite co-developed and filed with SunGen Pharma, LLC. The product is jointly owned by Elite and SunGen. Elite will manufacture and package the product on a cost-plus basis.
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. 
