USFDA has updated Paragraph IV certification list as of 21 February 2011. Table shows the newly added molecule.
DRUG NAME | DOSAGE FORM | STRENGTH | RLD | DATE OF SUBMISSION |
Clarithromycin | Extended-release Tablet | 500 mg | Biaxin XL | 12/6/2010 |
Dexlansoprazole | Delayed-release Capsule | 30 mg | Dexilant | 11/30/2010 |
Dexmethylphenidate Hydrochloride | Extended-release Capsule | 30 mg | Focalin XR | 12/15/2010 |
Diclofenac | Potassium Oral Solution (Sachet) | 50 mg | Cambia | 1/24/2011 |
Gatifloxacin | Ophthalmic Solution | 0.5% | Zymaxid | 12/7/2010 |
Oxycodone Hydrochloride | Extended-release Tablet | 10 mg | OxyContin (NDA 022272) | 10/25/2010 |
Oxycodone Hydrochloride | Extended-release Tablet | 15 mg | OxyContin (NDA 022272) | 10/28/2010 |
Oxycodone Hydrochloride | Extended-release Tablet | 20 mg | OxyContin (NDA 022272) | 10/29/2010 |
Oxycodone Hydrochloride | Extended-release Tablet | 30 mg, 60 mg and 80 mg | OxyContin (NDA 022272) | 10/18/2010 |
Oxycodone Hydrochloride | Extended-release Tablet | 40 mg | OxyContin (NDA 022272) | 10/4/2010 |
Tretinoin | Gel | 0.1% | Retin-A Micro | 7/8/2010 |
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