Thursday, 5 February 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 on 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 on 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 on 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, Para IV 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

No comments:

web page statistics
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)
 
eXTReMe Tracker