| 1 | Aceclofenac 200mg + Paracetamol 500mg Tablets | CTD Dossier |
| 2 | Aceclofenac 100mg + Paracetamol 325mg Tablets | CTD Dossier |
| 3 | Amoxicillin and Clavulanate potassium tablet USP 500 mg +125 mg | CTD Dossier |
| 4 | Amoxicillin and Clavulanate potassium tablet USP 875 mg +125 mg | CTD Dossier |
| 5 | Amoxicillin Trihydrate 125mg and Clavulanate Potassium Acid 31.25 mg oral suspension | CTD Dossier |
| 6 | Atorvastatin Calcium 10mg + Ezetimibe 10mg Tablet | CTD Dossier |
| 7 | Atorvastatin Calcium 20mg + Ezetimibe 10mg Tablet | CTD Dossier |
| 8 | Atracurium 10mg/ml - 2.5ml Injection | CTD Dossier |
| 9 | Atracurium 10mg/ml - 5ml Injection | CTD Dossier |
| 10 | Azithromycin Tablet USP 500 mg | CTD Dossier |
| 11 | Azithromycin for oral suspension 200 mg/ 5 ml, 22.5ml HDPE Bottle | ACTD Dossier |
| 12 | Azithromycin for oral suspension 200 mg/ 5 ml, 15ml HDPE Bottle | CTD Dossier |
| 13 | Anastrazole Tablets USP 1 mg | ACTD & CTD Dossier |
| 14 | Atorvastatin calcium Tablets 10 mg | CTD Dossier |
| 15 | Atorvastatin calcium Tablets 20 mg | CTD Dossier |
| 16 | Atorvastatin calcium Tablets 40 mg | CTD Dossier |
| 17 | Acetaminophen 500mg and Tramadol Hydrochloride 50mg Tablets USP | CTD Dossier |
| 18 | Alpha amylase Syrup | CTD Dossier |
| 19 | Alpha amylase Tablet | CTD Dossier |
| 20 | Azacitidine for Injection 100mg/vial | ACTD Dossier |
| 21 | Bacteriostatic Sodium Chloride Injection USP 0.9%, 30ml | CTD Dossier |
| 22 | Bupivacaine Hydrochloride in Dextrose Injection USP 5mg/ml, 4ml | CTD Dossier |
| 23 | Clomiphene citrate 50mg Tablets | CTD Dossier |
| 24 | Calcium Folinate Injection 50mg/5ml | CTD Dossier |
| 25 | Calcium gluconate 1000mg+Vit C 1000mg, Effervescent Tablets | CTD Dossier |
| 26 | Cefixime & Clavulanic Acid 100mg/62.5mg Tablets | CTD Dossier |
| 27 | Cefixime & Clavulanic Acid 200mg/125mg Tablet | CTD Dossier |
| 28 | Cefixime & Clavulanic Acid 50mg +31.25mg/ Suspension, 30ml Bottle | CTD Dossier |
| 29 | Cefixime & Clavulanic Acid 50mg +31.25mg/ Suspension, 60ml Bottle | CTD Dossier |
| 30 | Cefotaxime Sodium and Sulbactum Sodium Injection 250mg + 125mg | CTD Dossier |
| 31 | Cefotaxime Sodium and Sulbactum Sodium Injection 500mg + 250mg | CTD Dossier |
| 32 | Cefotaxime Sodium Injection 1g | CTD Dossier |
| 33 | Cefotaxime Sodium Injection 500mg | CTD Dossier |
| 34 | Cefpodoxime & Clavulanic Acid 100mg/ 62.5mg Tablets | CTD Dossier |
| 35 | Cefpodoxime & Clavulanic Acid 200mg + 125mg Tablets | CTD Dossier |
| 36 | Cefpodoxime & Clavulanic Acid 50mg + 31.25mg/ Suspension, 30ml Bottle | CTD Dossier |
| 37 | Cefpodoxime & Clavulanic Acid 50mg +31.25mg/ Suspension, 60ml Bottle | CTD Dossier |
| 38 | Ceftazidime 0.5 g injection, 10 ml | CTD Dossier |
| 39 | Ceftazidime 1 g injection, 20 ml | CTD Dossier |
| 40 | Ceftriaxone For Injection 500mg | CTD Dossier |
| 41 | Ceftriaxone For Injection USP 250 mg | CTD Dossier |
| 42 | Ceftriaxone Sodium Sterile For Injection 1000 mg | CTD Dossier |
| 43 | Ceftazidime 0.5g Injection, 7.5ml (Without WFI) | CTD Dossier |
| 44 | Ceftazidime 1g Injection, 10ml (Without WFI) | CTD Dossier |
| 45 | Cisplatin Injection 50mg/50ml | CTD Dossier |
| 46 | Clindamycin Phosphate Gel 1%, 30gm | CTD Dossier |
| 47 | Cabergoline tablets USP 0.5 mg | CTD Dossier |
| 48 | Cefotaxime 1000mg + Sulbactam 500mg injection | CTD Dossier |
| 49 | Cefixime tablet 400mg | CTD Dossier |
| 50 | Cefixime capsule 400mg | CTD Dossier |
| 51 | Cefepime sodium 1000mg & Sulbactam for Injection 1000mg | CTD Dossier |
| 52 | Ceftriaxone 1000mg + Sulbactam 500mg Injection | CTD Dossier |
| 53 | Cefixime for Oral Suspension USP 100mg/5ml | CTD Dossier |
| 54 | Clofazimine Capsules USP 100 mg | CTD Dossier |
| 55 | Docetaxel Injection 120mg/ 3ml | ACTD & CTD Dossier |
| 56 | Docetaxel Injection 20 mg/ 0.5ml | ACTD Dossier |
| 57 | Docetaxel Injection 40 mg/ ml, 2ml | ACTD Dossier |
| 58 | Docetaxel Injection 80mg/ 2ml | CTD Dossier |
| 59 | Domperidone 10 mg Oral dispersible tablets | CTD Dossier |
| 60 | Doxorubicin Hydrochloride Injection 2mg/ml, 25ml | CTD Dossier |
| 61 | Doxorubicin Hydrochloride Injection 2mg/ml, 5ml | CTD Dossier |
| 62 | Doxycycline Hyclate Tablets USP 100 mg | CTD Dossier |
| 63 | Dapoxetine Tablets 30mg | CTD Dossier |
| 64 | Dexamethasone 2mg + Thiamine nitrate 50mg + Pyridoxine Hcl 50mg + Cyanocobalamine 250mcg tablet | CTD Dossier |
| 65 | Dexamethasone 4mg + Thiamine nitrate 50mg + Pyridoxine Hcl 30mg + Cyanocobalamine 250mcg + Vitamin B6 50mg Injection, 3ml | CTD Dossier |
| 66 | Diclofenac Potassium + Cyanocobalamine + Prednisolone sodium phosphate Injection 75mg +5mg+10mg/3ml | CTD Dossier |
| 67 | Diclofenac Potassium 50mg + Cyanocobalamine 2.5mg + Vitamin D3 1000 IU Tablets | CTD Dossier |
| 68 | Diclofenac Potassium 50mg + Cyanocobalamine 3mg + Prednisolone 5mg Tablets | CTD Dossier |
| 69 | Diclofenac Potassium 75mg, Cyanocobalamin 5mg, Vitamin D3 1000 IU, 2ml Amp | CTD Dossier |
| 70 | Domperidone Oral Suspension 1mg/ml | CTD Dossier |
| 71 | Domperidone Oral Suspension 5 mg/5 ml | CTD Dossier |
| 72 | Dacarbazine for Injection USP 100mg | CTD Dossier |
| 73 | Empagliflozin Tablet 25mg | CTD Dossier |
| 74 | Empagliflozin Tablet 10mg | CTD Dossier |
| 75 | Ertapenem 1g Injection | CTD Dossier |
| 76 | Epirubicin Injection 10mg | CTD Dossier |
| 77 | Epirubicin Injection 50mg | CTD Dossier |
| 78 | Esomeprazole Sodium for Injection 40mg | CTD Dossier |
| 79 | Escitalopram Tablets USP 20 mg | CTD Dossier |
| 80 | Escitalopram Tablets 10 mg | CTD Dossier |
| 81 | Enoxaparin Sodium Injection USP 80 mg/0.8 ml. | CTD Dossier |
| 82 | Esomeprazole Gastro-resistant Granules BP 10mg (Sachet) | ACTD Dossier |
| 83 | Fenofibrate 145mg Tablet | CTD Dossier |
| 84 | Filgrastim Injection 300mcg/ml | CTD Dossier |
| 85 | Finasteride Tablet BP 5 mg | CTD Dossier |
| 86 | Fludarabine Phosphate Tablets 10mg | CTD Dossier |
| 87 | Fluorouracil Injection BP 500 mg/10 ml | CTD Dossier |
| 88 | Fluorouracil Injection 50 mg/ml, 5ml | CTD Dossier |
| 89 | Gemcitabine 1000mg Injection | ACTD & CTD Dossier |
| 90 | Gemcitabine 200mg Injection | ACTD & CTD Dossier |
| 91 | Glipizide 2.5mg +Metformin Hydrochloride 250mg Tablet | ACTD Dossier |
| 92 | Heparin Sodium 5000 IU/5ml injection | CTD Dossier |
| 93 | Humgica Capsule (Pre & probiotic vitamins and minerals capsules ) | ACTD Dossier |
| 94 | Humlac Capsule (Pre & Probiotic Capsule) | ACTD Dossier |
| 95 |
"Humlac Dry Syrup (Pre and Probiotic Granules for oral suspension)
"
|
ACTD Dossier |
| 96 | Humlac HP Capsule (Pre and Probiotic Capsules - DS ) | ACTD Dossier |
| 97 | Humlac - Zn Sachet (Pre and Probiotic with Glutamine and Zinc Sachets 1g) | ACTD Dossier |
| 98 | Humlac Sachet (Pre & Probiotic Sachets) | ACTD Dossier |
| 99 | Irinotecan Hydrochloride Injection 20 mg/ ml, 2ml | ACTD Dossier |
| 100 | Irinotecan Hydrochloride Injection 20 mg/ ml, 5ml | ACTD Dossier |
| 101 | Irinotecan Hydrochloride Injection 20 mg/ ml, 15ml | CTD Dossier |
| 102 | Iron 50mg (Dried ferrous sulfate 155mg) + Folic acid 0.35 mg (anhydrous), Pink film coated tablets | CTD Dossier |
| 103 | Iron Sucrose Injection 100mg/5ml | CTD Dossier |
| 104 | Ibuprofen Oral Suspension 100mg/5ml | CTD Dossier |
| 105 | Ketoprofen 100mg/2ml injection | CTD Dossier |
| 106 | Ketoprofen Suppository 100 mg | CTD Dossier |
| 107 | L-asparaginase Injection 10000 IU | CTD Dossier |
| 108 | Levofloxacin 500mg Tablets | CTD Dossier |
| 109 | Linezolid 600mg Tablet | CTD Dossier |
| 110 | Lidocaine Hydrochloride 20mg and adrenaline 12.5mcg Injection 2 % w/v & 1:80,000 | CTD Dossier |
| 111 | Lornoxicam for Injection 8 mg/Vial | CTD Dossier |
| 112 | Meloxicam 15mg + Cyanocobalamin 5mg + Betamethasone 0.30mg, 3ml ampoule | CTD Dossier |
| 113 | Meloxicam + Cyanocobalamin + Betamethasone Sodium Phosphate Tablets 7.5mg + 2.5mg +0.30mg | CTD Dossier |
| 114 | Metronidazole Oral Suspension 200mg/5ml, 100ml | CTD Dossier |
| 115 | Metronidazole 500 mg Tablet | ACTD & CTD Dossier |
| 116 | Metronidazole 500mg +Miconazole Nitrate 100mg Suppository | CTD Dossier |
| 117 | Moxifloxacin Hydrocholride 400mg Tablet | CTD Dossier |
| 118 | Memantine HCL tablets USP 10 mg | CTD Dossier |
| 119 | Meloxicam Tablets 15mg | CTD Dossier |
| 120 | Meropenem Injection 1g | CTD Dossier |
| 121 | Methylprednisolone Sodium Succinate for Injection 500mg | CTD Dossier |
| 122 | Methylprednisolone Sodium Succinate for Injection 250mg | CTD Dossier |
| 123 | Methylprednisolone Acetate Injectable Suspension USP 40mg/ml | CTD Dossier |
| 124 | Methylprednisolone Sodium Succinate for Injection USP 1gm | CTD Dossier |
| 125 | Nimodipine 30mg Tablet | CTD Dossier |
| 126 | Nifedipine 0.3%w/w and Lidocaine 1.5%w/w Cream | CTD Dossier |
| 127 | Omeprazole For Injection 40 mg/Vial | CTD Dossier |
| 128 | Omeprazole20mg+ Domperidone 10 mg Oral HG capsule | CTD Dossier |
| 129 | Oxaliplatin Injection 100mg/50ml | CTD Dossier |
| 130 | Oxaliplatin Injection 50mg/25ml | CTD Dossier |
| 131 | Paclitaxel Injection 100mg/16.7ml | CTD Dossier |
| 132 | Paclitaxel Injection 260mg/43.4ml | CTD Dossier |
| 133 | Paclitaxel injection 300mg/50ml | CTD Dossier |
| 134 | Paclitaxel Injection 30mg/5ml | CTD Dossier |
| 135 | Paclitaxel injection150mg/25ml | CTD Dossier |
| 136 | Pantoprazole Sodium 40mg + WFI Injection | CTD Dossier |
| 137 | Piroxicam 20 mg Oral dispersible tablets | CTD Dossier |
| 138 | Piroxicam 20 mg /ml Ampoule, lM/IV | CTD Dossier |
| 139 | Paracetamol 500mg +Tramadol 50mg Tablet | CTD Dossier |
| 140 | Propofol 10mg/ml , 20ml Injection | CTD Dossier |
| 141 | Pyrantel Pamoate Suspension 250mg/5ml,100ml | CTD Dossier |
| 142 | Prednisolone Tablets 20 mg | CTD Dossier |
| 143 | Prednisolone Tablets BP 5mg | CTD Dossier |
| 144 | Prednisolone Tablets BP 10mg | CTD Dossier |
| 145 | Prednisolone Tablets BP 40mg | CTD Dossier |
| 146 | Paracetamol 280mg+ Vitamin C 100 mg and Pheniramine Maleate 10mg Effervescence Tablet | CTD Dossier |
| 147 | Paracetamol 500mg+ Vitamin C 200 mg and Pheniramine Maleate 25mg Effervescence Tablet | CTD Dossier |
| 148 | Progesterone softgel capsule 200mg | CTD Dossier |
| 149 | Progesterone Suppository 400mg | CTD Dossier |
| 150 | Pantoprazole Tablets USP 40mg | CTD Dossier |
| 151 | Paracetamol Tablets 500mg | CTD Dossier |
| 152 | Prednisolone Acetate ophthalmic suspension USP 1%w/v | CTD Dossier |
| 153 | Rabeprazole Sodium for Injection 20mg | CTD Dossier |
| 154 | Recombinant Erythropoietin Injection 10000 IU | CTD Dossier |
| 155 | Silodosin 5mg Capsule | ACTD Dossier |
| 156 | Sorafenib 200mg tablets | ACTD Dossier |
| 157 | Silodosin 8mg Capsule | CTD Dossier |
| 158 | Tramadol & Paracetamol tablets (50mg+500mg) | CTD Dossier |
| 159 | Triptorelin Acetate Injection 3.75mg | CTD Dossier |
| 160 | Triptorelin Pamoate for Injectable Suspension 3.75mg | CTD Dossier |
| 161 | Triptorelin Pamoate for Injectable Suspension 11.25mg | CTD Dossier |
| 162 | Thalidomide Tablets 100mg | CTD Dossier |
| 163 | Vardenafil 20 mg tablet | CTD Dossier |
| 164 | Vardenafil 5 mg tablet | CTD Dossier |
| 165 | Vitamin B complex Injection | CTD Dossier |
| 166 | Vinorelbine Injection 10mg/ml,5ml | CTD Dossier |
| 167 | Vincristine sulphate 1 mg injection | ACTD Dossier |
| 168 | Zoledronic Acid Injection 4mg | CTD Dossier |
| 169 | Ivermectin Tablet 3mg | CTD Dossier |
| 170 |
"Betamethasone Sodium Phosphate & Betamethasone Acetate
Injectable Suspension USP 6ml/ml"
|
CTD Dossier |
| BE STUDIES AVAILABILITY |
| 1 | Cefpodoxime & Clavulanic Acid 200mg + 125mg Tablet | CTD Dossier & BE Study |
| 2 | Cefpodoxime & Clavulanic Acid 100mg/ 62.5mg Tablets | CTD Dossier & BE Study |
| 3 | Cefixime & Clavulanic Acid 50mg +31.25mg/ Suspension, 30ml Bottle | CTD Dossier & BE Study |
| 4 | Cefixime & Clavulanic Acid 50mg +31.25mg/ Suspension, 60ml Bottle | CTD Dossier & BE Study |
| 5 | Cefixime & Clavulanic Acid 200mg/125mg Tablet | CTD Dossier & BE Study |
| 6 | Cefixime & Clavulanic Acid 100mg/62.5mg Tablets | CTD Dossier & BE Study |
| 7 | Cefpodoxime & Clavulanic Acid 50mg + 31.25mg/ Suspension, 30ml Bottle | CTD Dossier & BE Study |
| 8 | Cefpodoxime & Clavulanic Acid 50mg +31.25mg/ Suspension, 60ml Bottle | CTD Dossier & BE Study |
| 9 | Azithromycin Tablet USP 500 mg | CTD Dossier & BE Study |
| 10 | Doxycycline Hyclate Tablets USP 100 mg | CTD Dossier & BE Study |
| 11 | Clindamycin Phosphate Gel 1%, 30gm | CTD Dossier & BE Study |
| 12 | Pyrantel Pamoate Suspension 250mg/5ml, 100ml | CTD Dossier & BE Study |
| 13 | Rifaximin Tablets 200mg | CTD Dossier & BE Study |
| 14 | Vardenafil 20mg Tablets | CTD Dossier & BE Study |
| 15 | Amoxicillin + Clavulanate potassium 875 mg + 125 mg Tablets | CTD Dossier & BE Study |
| 16 | Silodosin Capsule 8mg | CTD Dossier & BE Study |
| 17 | Clofazimine Capsule 100mg | CTD Dossier & BE Study |
| 18 | Levofloxacin Tablets 500mg | CTD Dossier & BE Study |
| 19 | Esomeprazole Gastro-resistant Granules BP 10mg | CTD Dossier & BE Study |
| 20 | Cefixime for Oral Suspension 100 mg / 5 ml | CTD Dossier & BE Study |