Saturday, 10 October 2009

New Paragraph IV certifications reported by USFDA from Sep 8, 2009 to Oct 8, 2009

1) Mycophenolic Acid (Myfortic) 180 mg Delayed-release Tablets: Para IV filed on June 4, 2009

2) Nisoldipine (Sular ) 8.5 mg and 17 mg Extended-release Tablets: Para IV filed on March 2, 2009

3) Telmisartan and Hydrochlorothiazide (Micardis HCT) 80 mg+25 mg Tablets: Para IV filed on Feb 27, 2009

4) Tramadol Hydrochloride (Ryzolt )100 mg, 200 mg and 300 mg ER Tablets: Para IV filed on June 18, 2009

5) Carbidopa, Levodopa and Entacapone (Stalevo 75 and Stalevo 125) Tablets: Para IV filed on May 19, 2009

6) Ephinephrine (Epipen) Injection: Para IV filed on Nov 21, 2008

7) Docetaxel (Taxotere) Injection 40mg/mL, 0.5mL and 2mL vials: Para IV filed on June 30, 2009

8) Piperacillin and Tazobactam (Zosyn) For Injection 2.25 g/vial, 3.375 g/vial, 4.5 g/vial: Para IV filed before Feb 5, 2009

9) Repaglinide and Metformin (Prandimet) 1 mg + 500 mg and 2 mg + 500 mg Tablets : Para IV filed on April 9, 2009

Source: USFDA website Here

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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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