First-Time Generic Drug Approvals: January 2009
- Galantamine Hydrobromide Oral Solution 4 mg/mL
Approved: January 30, 2009 Roxane Laboratories, Inc.
Generic for: Razadyne Oral Solution
- Risperidone Oral Solution 1 mg/mL
Approved: January 30, 2009 Teva Pharmaceuticals USA
Generic for: Risperdal Oral Solution
- Divalproex Sodium Extended-Release Tablets 250 mg and 500 mg
Approved: January 29, 2009 Mylan Pharmaceuticals, Inc.
Generic for: Depakote ER Tablets, 250 mg and 500 mg
- Divalproex Sodium Delayed Release Capsules (Sprinkle) 125 mg (valproic acid equivalent)
Approved: January 23, 2009 Dr. Reddy's Laboratories, Inc.
Generic for: Depakote Sprinkle Capsules, 125 mg
- Levetiracetam Oral Solution 100 mg/mL
Approved: January 15, 2009 Roxane Laboratories, Inc.; Tolmar Inc.; Aurobindo Pharma Ltd.; Actavis Mid Atlantic LLC
Generic for: Keppra Oral Solution
- Alprazolam Orally Disintegrating Tablets 0.25 mg, 0.5 mg, 1 mg and 2 mg
Approved: January 9, 2009 Kali Laboratories, Inc.
Generic for: Niravam Orally Disintegrating Tablets
Generic Approvals Archive
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