Monday, 10 August 2009

Paragraph IV filings reported by USFDA (June-July, 2009)

1. Candesartan Cilexetil and Hydrochlorothiazide (Atacand HCT) Tablets 32 mg+25 mg Paragraph IV filed on March 6, 2009 (Earlier, a generic company has filed Paragraph IV against Atacand HCT Tablets 16 mg+12.5mg and 32mg+12.5mg on June 25, 2008)


2. Diazepam (Diastat Acudia) Rectal Gel 5 mg/ml, 4mL pre-filled syringe Paragraph IV filed on Dec 8, 2008 and for 2mL pre-filled syringe on Dec 23, 2008


3. Mycophenolic acid (Myfortic) Delayed-release Tablets 360 mg Paragraph IV filed on Feb 2, 2009


4. Telmisartan and Hydrochlorothiazide (Micardis HCT) Tablets 80 mg/12.5 mg and 80 mg/25 mg Paragraph IV filed on Dec 31, 2008


5. Vardenafil hydrochloride (Levitra) Tablets 20 mg Paragraph IV filed on March 5, 2009


6. Doxercalciferol Capsules (Hectorol) 0.5 mcg and 2.5 mcg Paragraph IV filed on March 25, 2009


7. Atovaquone and Proguanil Hydrochloride 250/100 mg tablets Para IV filed on April 3, 2009


9. Efavirenz (Sustiva) 600 mg tablets Para IV filed on April 9, 2009

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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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