First-Time Generic Drug Approvals: October 2010

• Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension equivalent to 10 mg hydrocodone bitartrate and 8 mg chlorpheniramine maleate per 5 mL
  Approved: October 1, 2010 - Tris Pharma, Inc.
  Generic for: Tussionex Pennkinetic Extended-Release Oral Suspension
• Zolpidem Tartrate Extended-Release Tablets USP 6.25 mg
  Approved: October 13, 2010 - Actavis South Atlantic LLC
  Generic for: Ambien CR
• Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg and 30 mg
  Approved: October 15, 2010 - Teva Pharmaceuticals USA
  Generic for: Prevacid SoluTab Delayed-Release Orally Disintegrating Tablets
• Propafenone Hydrochloride Extended-Release Capsules 225 mg, 325 mg and 425 mg
  Approved: October 18, 2010 - Par Pharmaceutical, Inc.
  Generic for: Rythmol SR Capsules

Generic Approvals Archive