| |
|
LIST OF SUBMISSION STUDIES |
|
| S.NO. |
STUDY NO. |
MOLECULE |
REGULATORY |
| 1 |
005/06BA |
ALLOPURINOL |
BELGIUM |
| 2 |
033/06CL |
BICALUTAMIDE |
EU |
| 3 |
055/06CL |
ANASTROZOLE |
USFDA |
| 4 |
056/06CL |
ANASTROZOLE |
USFDA |
| 5 |
100/07 |
KETOROLAC |
RUSSIA |
| 6 |
135/07 |
BISOPROLOL FUMERATE |
SOUTH AFRICA |
| 7 |
145/07CL |
LETROZOLE |
USFDA |
| 8 |
146/07CL |
LETROZOLE |
USFDA |
| 9 |
200/08 |
CIPROFLAXACIN |
RUSSIA |
| 10 |
201/08 |
ENALAPRIL |
RUSSIA |
| 11 |
254/08 |
AZITHROMYCIN |
USFDA |
| 12 |
269/08 |
NORETHINDRONE+ETHINYL ESTRADIOL |
USFDA |
| 13 |
274/08CL |
NORETHINDRONE(NOR-QD) |
USFDA |
| 14 |
276/08CL |
NORETHINDRONE(Orthomicronor) |
USFDA |
| 15 |
319/08 |
ANASTROZOLE |
CANADA |
| 16 |
337/08 |
PIOGLITAZONE |
USFDA |
| 17 |
338/08 |
PIOGLITAZONE |
USFDA |
| 18 |
341/08 |
NORETHINDRONE+ETHINYL ESTRADIOL |
USFDA |
| 19 |
342/08CL |
ETHINYAL ESTRODIAL SEASONIQUE |
USFDA |
| 20 |
343/08CL |
LEVONORGESTREL+ETHINYL ESTRADIOL |
USFDA |
| 21 |
344/08CL |
LEVONORGESTREL+ETHINYL ESTRADIOL |
USFDA |
| 22 |
349/09 |
TRIMETHOPRIME |
USFDA |
| 23 |
355/09 |
TROSPIUM CHLORIDE |
USFDA |
| 24 |
356/09 |
TROSPIUM CHLORIDE |
USFDA |
| 25 |
394/09CL |
LEVONORGESTREL+ETHINYL ESTRADIOL |
USFDA |
| 26 |
394/09CL |
TROSPIUM |
USFDA |
| 27 |
394/09CL |
TROSPIUM |
USFDA |
| 28 |
417/09 |
AZITHROMYCIN |
USFDA |
| 29 |
423/09 |
NORGESTIMATE & ETHINYL ESTRADIOL |
USFDA |
| 30 |
LABE-431-09 |
LABETALOL |
USFDA |
| 31 |
PHYT-450-09 |
PHYTONADIONE |
USFDA |
| 32 |
FENO-470-09 |
FENOFIBRATE |
USFDA |
| 33 |
LABE-432-09 |
LABETALOL |
USFDA |
| 34 |
URSO-484-09 |
URSODIOL FED |
USFDA |
| 35 |
AZIT-469-09 |
AZITHROMYCIN |
USFDA |
| 36 |
STAV-449-09 |
STAVUDINE+LAMUVIDINE+NEVIRAPINE |
WHO |
| 37 |
DICL-516-09 |
DICLOFENAC+MISOPROSTOL |
USFDA |
| 38 |
SRNX-09302 (LEVO-529-09) |
LEVONORGESTREL + ETHINYL ESTRADIOL |
USFDA |
| 39 |
MIRT-497-09 |
MIRTAZAPINE |
FRANCE |
| 40 |
CEFU-505-09 |
CEFUROXIME |
MHRA (UK) |
| 41 |
LEVO-524-09 |
LEVONORGESTREL (PLAN B ONE STEP) |
USFDA |
| 42 |
NORE-522-09 |
NORETHINDRONE 0.35 MG (ORTHOMICRONOR) |
USFDA |
| 43 |
NORE-523-09 |
NORETHINDRONE 0.35 MG (ORTHOMICRONOR) |
USFDA |
| 44 |
FAMO-491-09 |
FAMOTIDINE 40MG/ 5 ML |
USFDA |
| 45 |
IRBE-534-09 |
IRBESARTAN 300 MG |
USFDA |
| 46 |
IRBE-535-09 |
IRBESARTAN |
USFDA |
| 47 |
NORE-536-09 |
NORETHINDRONE + ETHINYL ESTRADIOL (OVCON) |
USFDA |
| 48 |
NORE-537-09 |
NORETHINDRONE + ETHINYL ESTRADIOL (OVCON) |
USFDA |
| 49 |
CEFU-566-10 |
CEFUROXIME ORAL SUSPENSION |
MHRA (UK) |
| 50 |
ZOLP-549-10 |
ZOLPIDEM TARTRATE |
USFDA |
| 51 |
FAMO-567-10 |
FAMOTIDINE 40MG/ 5 ML |
USFDA |
| 52 |
OXYB-568-10 |
OXYBUTYNIN |
USFDA |
| 53 |
NITR-544-09 |
NITROFURANTOIN |
USFDA |
| 54 |
ZOLP-551-10 |
ZOLPIDEM TARTRATE |
USFDA |
| 55 |
BISO-584-10 |
BISOPROLOL FUMERATE |
CANADA |
| 56 |
LEVO-519-09 |
LEVOFLOXACIN |
USFDA |
| 57 |
CEFU-562-10 |
CEFUROXIME 500 mg TABLETS |
MHRA (UK) |
| 58 |
LEVO-520-09 |
LEVOFLOXACIN |
USFDA |
| 59 |
LAMI-602-10 |
LAMIVUDINE |
USFDA |
| 60 |
IRBE-626-10 |
IRBESARTAN |
USFDA |
| 61 |
CLON-574-10 |
CLONAZEPAM |
USFDA |
| 62 |
TRIM-548-10 |
TRIMETAZIDINE |
PHILLIPINES |
| 63 |
OXYB-633-10 |
OXYBUTYNIN |
USFDA |
| 64 |
OXYB-634-10 |
OXYBUTYNIN |
USFDA |
| 65 |
LAMI-601-10 |
LAMIVUDINE |
USFDA |
| 66 |
CLAR-642-10 |
CLARITHROMYCIN |
USFDA |
| 67 |
CLON-573-10 |
CLONAZEPAM |
USFDA |
| 68 |
ZIPR-652-10 |
ZIPRASIDONE |
CANADA |
| 69 |
LAMI-657-10 |
LAMIVUDINE |
USFDA |
| 70 |
CLAR-641-10 |
CLARITHROMYCIN 500mg USP |
USFDA |
| 71 |
FAMO-639-10 |
FAMOTIDINE + CALCIUM CARBONATE + MAGNESIUM HYDROXIDE |
USFDA |
| 72 |
FAMO-638-10 |
FAMOTIDINE + CALCIUM CARBONATE + MAGNESIUM HYDROXIDE |
USFDA |
| 73 |
DONE-672-10 |
DONEPEZIL HYDROCHLORIDE 23 mg |
USFDA |
| 74 |
DONE-701-10 |
DONEPEZIL HYDROCHLORIDE 23 mg |
USFDA |
| 75 |
AZIT-690-10 |
AZITHROMYCIN ORAL SUSPENSION 200 mg / 5 mL |
USFDA |
76 |
LEVO-668-10 |
LEVONORGESTREL + ETHINYL ESTRADIOL (SEASONIQUE) |
USFDA |
77 |
FEXO-721-10 |
FEXOFENADINE HYDROCHLORIDE 180 mg |
AUSTRALIA |
78 |
URSO-663-10 |
URSODEOXYCHOLIC ACID 250 mg |
FRANCE |
79 |
CLAR-725-10 |
CLARITHROMYCIN 500 mg |
USFDA |
80 |
DONE-753-10 |
DONEPEZIL HYDROCHLORIDE 23 mg |
USFDA |
81 |
NITR-750-10 |
NITROGLYCERIN SUBLINGUAL TABLETS 0.6 mg |
USFDA |
82 |
DONE-754-10 |
DONEPEZIL HYDROCHLORIDE 23 mg |
USFDA |
83 |
ORPH-746-10 |
ORPHANEDRINE CITRATE |
USFDA |
84 |
AZIT-689-10 |
AZITHROMYCIN ORAL SUSPENSION 200 mg / 5 Ml |
USFDA |
85 |
CLAR-640-10 |
CLARITHROMYCIN 250 mg |
USFDA |
86 |
LEVE-790-10 |
LEVETIRACETAM |
USFDA |
87 |
PRAM-586-10 |
PRAMIPEXOLE DIHYDROCHLORIDE 0.25 mg |
USFDA |
88 |
PRAM-587-10 |
PRAMIPEXOLE DIHYDROCHLORIDE 0.25 mg |
USFDA |
89 |
PRAM-810-10 |
PRAMIPEXOLE DIHYDROCHLORIDE 0.375 mg |
USFDA |
90 |
NORG-786-10 |
NORGESTREL + ETHINYL ESTRADIOL (LOW-OGESTREL) 0.30 mg /0.030 mg |
USFDA |
91 |
NORG-788-10 |
NORGESTIMATE + ETHINYL ESTRADIOL (ORTHO TRI-CYCLEN) 0.250 mg/ 0.035 mg |
USFDA |
92 |
DICL-831-11 |
DICLOFENAC POTASSIUM 50 mg OF ORAL SOLUTION |
USFDA |
93 |
NORG-787-10 |
NORGESTREL + ETHINYL ESTRADIOL (LOW-OGESTREL) 0.30 mg /0.030 mg |
USFDA |
94 |
GABA-823-11 |
GABAPENTIN 800 mg |
USFDA |
95 |
LANS-834-11 |
LANSOPRAZOLE ODT FED STUDY |
AUSTRALIA |
96 |
EFAV-833-11 |
EFAVIRENZ 600 mg |
USFDA |
97 |
NORG-789-10 |
NORGESTIMATE + ETHINYL ESTRADIOL (ORTHO TRI-CYCLEN) 0.250 mg/ 0.035 mg |
USFDA |
98 |
DICL-832-11 |
DICLOFENAC POTASSIUM 50 mg OF ORAL SOLUTIO |
USFDA |
99 |
CLAR-667-10 |
CLARITHROMYCIN ER 500 mg TABLETS |
USFDA |
100 |
AMLO-828-11 |
AMLODIPINE + ATORVASTATIN 10 / 80 mg |
CANADA |
101 |
LANS-850-11 |
LANSOPRAZOLE ODT FASTING STUDY |
AUSTRALIA |
102 |
FELO-829-11 |
FELODIPINE ER 10 mg |
USFDA |
103 |
BUME-807-10 |
BUMETANIDE 2 mg |
USFDA |
104 |
GABA-897-11 |
GABAPENTIN 800 mg |
USFDA |
105 |
CLAR-653-10 |
CLARITHROMYCIN ER 500 mg FED |
USFDA |
106 |
NORE-912-11 |
NORETHINDRONE ACETATE + ETHINYL ESTRADIOL 1.0 mg/ 10mcg (LO-LOESTRIN FE) |
USFDA |
107 |
NORE-913-11 |
NORETHINDRONE ACETATE + ETHINYL ESTRADIOL 1.0 mg/ 10mcg (LO-LOESTRIN FE) |
USFDA |
108 |
GABA-824-11 |
GABAPENTIN 800 mg |
USFDA |
