USFDA has updated Paragraph IV certification list as of July 25, 2011. Table shows the newly added molecule.
DRUG NAME | DOSAGE FORM | STRENGTH | RLD | DATE OF SUBMISSION |
Megestrol Acetate | Oral Suspension | 125 mg/mL | Megace ES | 4/27/2011 |
Norethindrone Acetate and Ethinyl Estradiol / Ethinyl Estradiol and Ferrous Fumarate | Tablets | 1 mg/0.01 mg, 0.01 mg and 75 mg | Lo Loestrin Fe | 4/29/2011 |
Palonosetron Hydrochloride | Injection | 0.05 mg/mL, 1.5 mL and 5 mL vials | Aloxi | 5/27/2011 |
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