Wednesday, August 26, 2009

Paragraph IV certification reported by USFDA (June-August, 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
6. Solifenacin Succinate Tablets (Vesicare) Para IV filed on April 8, 2009
7. Dexmedetomidine Injection (Precedex) 100 mcg/mL Para IV filed on April 8, 2009
8. Quetiapine Fumarate Extended-release Tablets 150 mg (Seroquel XR) Para IV filed on Nov 17, 2008
9. 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)
10. 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
11. Mycophenolic acid (Myfortic) Delayed-release Tablets 360 mg Paragraph IV filed on Feb 2, 2009
12. Telmisartan and Hydrochlorothiazide (Micardis HCT) Tablets 80 mg/12.5 mg and 80 mg/25 mg Paragraph IV filed on Dec 31, 2008
13. Vardenafil hydrochloride (Levitra) Tablets 20 mg Paragraph IV filed on March 5, 2009
14. Doxercalciferol Capsules (Hectorol) 0.5 mcg and 2.5 mcg Paragraph IV filed on March 25, 2009
15. Atovaquone and Proguanil Hydrochloride 250/100 mg tablets Para IV filed on April 3, 2009
16. Efavirenz (Sustiva) 600 mg tablets Para IV filed on April 9, 2009

(Source: USFDA)

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