Wednesday, July 27, 2011

USFDA Paragraph IV updation

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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