Wednesday, February 4, 2009

Paragraph IV certification reported by USFDA from November 2008 till February 3, 2009

Carbidopa+ Levodopa + Entacapone (Stalevo) Tablets 12.5 mg, 50 mg and 200 mg 50 on August 5, 2008 and 50mg/200mg/200mg on Aug 28, 2008
Duloxetine (Cymbalta) Delayed-release Capsules 20 mg, 30 mg and 60 mg on Aug 4, 2008
Emtricitabine and Tenofovir Disoproxil (Truvada) Tablets 200 mg/300 mg on September 26, 2008
Fluticasone (Cutivate) Lotion 0.05% on July 28, 2008
Pramipexole (Mirapex) Tablets 0.75 mg on July 31, 2008
Zoledronic acid (Reclast) Injection 0.05 mg/mL, 100 mL vial n Aug 29, 2008
Clobetasol ( Clobex) Spray 0.05% on Septemeber 29, 2008
Desflurane (Suprane) Inhalation 99.9% on September 11, 2008
Fenofibrate (Antara) Capsules 43 mg and 130 mg on September 15, 2008
Lovastatin and Niacin (Advicor) Extended-release Tablets 20 mg/500 mg September 22, 2008
Olopatadine (Pataday) Ophthalmic Solution 0.2% on September 8, 2008
Tadalafil (Cialis) Tablets 2.5 mg on October 14, 2008
Testosterone (Testim) Gel 1% on October 21, 2008
Montelukast (Singular Granules) Oral Granules 4 mg on October 17, 2008
Paricalcitol (Zemplar) Capsules 1 mcg and 2 mcg on October 14, 2008
Risedronate (Actonel) Tablets 150 mg on October 8, 2008
Metformin Hydrochloride (Fortamet) 500 mg and 1000 mg Extended-release Tablets on October 14, 2008
Pemetrexed Disodium (Alimta)100 mg/vial For Injection July 1, 2008
Metformin (Fortamet) Extended-release Tablets 500 and 1000mg on October 14, 2008
Pemetrexed (Alimta) For Injection 100 mg/vial on July 1, 2008
Aprepitant (Emend) Capsule 40 mg, 80 mg and 125 mg on November 3, 2008
Bortezomib (Velcade) For Injection 3.5 mg/vial on November 20, 2008
Conjugated Estrogen (Synthetic A) (Cenestin) Tablet 1.25 mg on November 3, 2008
Epinastine (Elestat) Ophthalmic Solution 0.05% on October 14, 2008
Eptifibatide (Integrilin) Injection 2 mg/mL, 10 mL vial on September 30, 2008
Lanthanum (Fosrenol) Chewable Tablet 500 mg, 750 mg and 1000 mg on October 27, 2008
lopinavir and Ritonavir (Kaletra) Tablets 100 mg/25 mg and 200 mg/50 mg on December 23, 2008
Metronidazole (Metrogel) Topical Gel 1% on October 21, 2008
Minocycline (Solodyn) Extended-release Tablet 45 mg, 90 mg and 135 mg before Feb 5, 2009
Rropinirole (Requip XL) Extended-release Tablet 2 mg on October 14, 2008
Doxycycline Hyclate (Doryx) 75 mg and 100 mg before Feb 5, 2009
(Source: USFDA)
 
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