Thursday 27 August, 2009

Paragraph IV certification reported by USFDA (August 25, 2009)

1. Amlodipine Besylate and Atorvastatin Calcium 5 mg + 80 mg tablets (Caduet) Paragraph IV filed on April 4, 2009


2. Fluvoxamine Maleate Extended- release Capsules (Luvox CR) Paragraph IV filed for 100 mg strength on May 18, 2009 and for 150 mg strength on April 13, 2009


3. Minoxidil 5% Topical Aerosol Foam (Men’s Rogaine) Paragraph IV filed on April 6, 2009


4. Paroxetine Hydrochloride 37.5 mg Extended-release Tablets (Paxil CR) Paragraph IV filed May 19, 2009


5. Testosterone 1% Gel Metered-dose Pump (Androgel) Paragraph IV filed on December 19, 2008


(Source: USFDA website)

Posted by ADKS at 5:45 pm

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Disclaimer: "IP Pharma Doc" blog is published for information purpose only. "IP Pharma Doc" blog contains no legal advice. I assume no legal responsibility for the views/information expressed here. “IP Pharma Doc” blog is my personal website and not edited by my employer, accordingly, no part of my blog should be attributed to my employer. All information on the present blog should be double checked for its accuracy and applicability. © Dr. Sarwal (2007)
 
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