Friday, November 11, 2011

Paragraph IV certification update

USFDA has updated Paragraph IV certification list as of Nov 07, 2011. Table shows the newly added molecule.


DRUG NAMEDOSAGE FORMSTRENGTHRLDDATE OF SUBMISSION
Pioglitazone Hydrochloride and Metformin Hydrochloride
Extended-release Tablets
15 mg/1000 mg and 30 mg/1000 mg
Actoplus Met XR
9/23/2011
Oseltamivir Phosphate
Capsules
30 mg and 45 mg
Tamiflu8/2/2011
Doripenem
Injection
250 mg/vial and 500 mg/vial
Doribax10/12/2011
Dasatinib
Tablets
80 mg and 140 mg
Sprycel6/17/2011
Fluticasone Furoate
Nasal Spray
27.5 mcg
Veramyst7/15/2011
Ketorolac Tromethamine
Opthalmic Solution
0.45%
Acuvail8/24/2011

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