Products - EU CTD Dossier List

EU CTD Dossier List

Sr # Product Name Dosage Form Strength Dossier Availability MA Availability/Filing Date Therapeutic Class
1 Aripiprazole Tablet 5/10/15/30 mg Available On going DCP Anti-psychotic
2 Atazanavir Capsule 150/200/300mg August-16 Filing- Sept 16 Anti-retro viral
3 Candesartan Tablet 2/4/8/16/32 mg Available - Anti-hypertensive
4 Candesartan + HCTZ Tablet 16+12.5 mg Available - Anti-hypertensive
5 Celecoxib Capsule 100/200 mg Available MA (UK,DE,IT,ES) NSAID (Pain/Inflammation)
6 Cinacalcet Tablet 30/60/90mg March-16 Filing - Dec 16 Anti- Hyperthyroidism
7 Clopidogrel Tablet 75 mg Available MA(UK,DE,IT) Anti-platelet
8 Colchicine Tablet 0.5mg/1mg April-16 Filing- May 16 Anti Gout
9 Donepezil Tablet 5mg/10mg Available MA(UK,DE,IT) Anti-psychotic
10 Donepezil ODT OD Tablet 5mg/10mg Available - Anti-psychotic
11 Efavirenz Tablet 600mg February-16 Filing-March 16 Anti-retro viral
12 Escitalopram Tablet 5/10/20 mg Available MA(UK,DE,IT) Anti-depressant
13 Febuxostat Tablet 80mg/120mg March-16 Filing April-16 Anti-gout
14 Irbesartan Tablet 75/150/300 mg Available MA(UK,ES,IT) Anti-hypertensive
15 Irbesartan + HCTZ Tablet 150+12.5/300+12.5/ 300+25 mg Available MA(UK,ES,IT) Anti-hypertensive
16 Lacosamide Tablet 50/100/150/200mg August-16 Filing - Sept 16 Anti-psychotic
17 Levofloxacin Tablet 250/500mg Available MA (UK,DE,ES,IT,HU,RO) Anti-bacterial
18 Linezolid Tablet 600mg April-16 Filing- May 16 Antibiotics
19 Memantine HCL Tablet 10/20 mg Available MA(PT,UK,DE,IT) Anti-psychotic
20 Montelukast Tablet 10 mg Available - Anti-Asthmatic/ Bronchospasm Prophylaxis
21 Moxifloxacin Tablet 400mg January-16 Filing - Feb 16 Antibiotics
22 Nebivolol Tablet 2.5/5/10mg March-16 Filing April-16 Anti Hypertensive
23 Norfloxacin Tablet 400mg December-15 Filing- January 16 Antibiotics
24 Olmesartan Tablet 10/20/40 mg Available On going DCP Anti-hypertensive
25 Olmesartan + HCTZ Tablet 20+12.5/20+25 mg Available On going DCP Anti-hypertensive
26 Pantoprazole DR Tablet 20/40 mg Available MA (UK,DE,IT,HU,RO) Anti-Ulcers, Erosive esophgitis
27 Pregabalin Capsule 150/200/ 225/300 mg February-16 Filing - March 16 Anti-convulsant
28 Raloxifene Tablet 60mg December-15 Filing- January 16 Anti-Osteoporotic
29 Rasagiline Tablet 1mg February-17 Filing - March 17 Anti-parkinson
30 Rosuvastatin Tablet 5/10/20/40 mg Available On going DCP Anti-hyperlipidemic
31 Sildenafil Tablet 25/50/100 mg Available MA(UK,DE,ES,IT,RO) Erectile dysfunction
32 Tadalafil Tablet 2.5/5/10/20 mg Available Filing - Oct 15 Erectile dysfunction
33 Tamsulosin ER Capsule 0.4 mg Available On going DCP Benign Prostatic Hyperplasia(BPH)
34 Tenofovir Tablet 300 mg March-16 Filing - April 16 Anti-retro viral
35 Tenofovir+Emtricitabine Tablet 300+200mg June-20 Filing -July 22 Anti-retro viral
36 Tenofovir+Emtricitbine+Efavirenz Tablet 300+200+600mg January-18 Filing- Feb 20 Anti-retro viral
37 Tolterodine ER Capsule 2mg/4mg March-16 Filing - April 16 Anti- Spasmodic
38 Valsartan Tablet 40/80/160/320 mg Available MA(UK,DE,IT) Anti-hypertensive
39 Valsartan + HCTZ Tablet 160+25 mg Available MA(UK,DE,ES,IT) Anti-hypertensive
40 Venlafaxine ER Capsule 37.5/75/150 mg December-15 Filing - January 16 Anti- Depressant

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