Friday 13 November, 2009

New Paragraph IV certifications reported by USFDA From Oct, 2009 to 5th November, 2009

1) Diclofenac Sodium and Misoprostol (Arthrotec) 50 mg + 0.2 mg DR Tablets : Paragraph IV filed on June 29, 2009

2) Fluvoxamine Maleate 100 mg Capsules (Luvox CR) 5 mg ad 10 mg Tablets: Para IV filed on April 20, 2009

3) Glycopyrrolate (Robinul Forte) 1.5 mg Tablets : Para IV filed on May 6, 2009

4) Vardenafil (Levitra) 5 mg ad 10 mg Tablets: Para IV filed on July 10, 2009

5) Amoxicillin and Clavulanate Potassium (Augmentin XR) 1000 mg + 62.5 mg ER tablets : Para IV filed on Jan 21, 2009

6) Armodafinil (Nuvigil) 50 mg, 150 mg and 250 mg: Para IV filed on July 24, 2009; for the other stregths like 100 mg and 200 mg, Para IV filed on Sep 11, 2009

7) Atazanavir Sulfate (Reyataz) 300 mg Capsules: Para IV filed on July 20, 2009

8) Caspofungin Acetate (Cancidas) 50 mg and 70 mg vial for injection: Para IV filed on June 26, 2009

9) Cisatracurium Besylate (Nimbex) 2 mg/mL, 5 mL vial and 10 mg/mL, 20 mL vial: Para IV filed on Aug 4, 2009; 2 mg/mL, 10 mL vial Para IV filed on Aug 12, 2009

10) Ezetimibe and Simvastatin (Vytorin) 10 mg + 10 mg, 10 mg + 20 mg, 10 mg + 40 mg and 10 mg + 80 mg Tablets: Para IV filed on July 27, 2009

11) Olopatadine Hydrochloride (Patanase) 0.665 mg/Spray (Nasal Spray): Para IV filed on June 29, 2009

12) Metformin Hydrochloride (Glumetza) 500 mg and 1000 mg ER tablets: Para IV filed on July 27, 2009

13) Mometasone Furoate (Nasonex ) 50 mcg/nasal spray: Para IV filed on Aug 7, 2009

14) Morphine Sulfate (Avinza) 45 mg and 75 mg ER capsules: Para IV filed on July 30, 2009

15) Ramelteon 8 mg Tablets (Rozerem): Para IV filed on July 22, 2009

16) Sibutramine Hydrochloride (Meridia) 10 mg and 15 mg: Para IV filed on Aug 14, 2009


17) Tigecycline (Tygacil) For Injection 50 mg per vial: Para IV filed on June 15, 2009

18) Tobramycin (Tobi) 300 mg/5 ml Inhalation Solution: Para IV filed on June 29, 2009

19) Linezolid (Zyvox) 100 mg/5 ml Oral Suspension: Para IV filed on Aug 3, 2009

Source: USFDA Para IV list Here

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