USFDA has updated Paragraph IV certification list as of April 18, 2011. Table shows the newly added molecule.
DRUG NAME | DOSAGE FORM | STRENGTH | RLD | DATE OF SUBMISSION |
Glycopyrrolate | Tablets | 1 mg | Robinul | 8/14/2009 |
Glycopyrrolate | Tablets | 2 mg | Robinul Forte | 10/12/2010 |
Hydromorphone hydrochloride | Oral Solution | 5 mg/5mL | Dilaudid | 2/25/2011 |
Azithromycin | Ophthalmic Solution | 1% | Azasite | 3/3/2011 |
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