| View |
|
DR-XY49108
|
Piperacillin (as sodium) + Tazobactam (as sodium)
|
Aezitam 2.25
|
2 g/250 mg
|
Powder for Injection (I.M./I.V.)
|
Antibacterial (Penicillin/ Beta-Lactamase Inhibitor)
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
18 June 2024
|
18 June 2029
|
| View |
|
DR-XY49109
|
Telmisartan
|
Telarb
|
40 mg
|
Tablet
|
Angiotensin II Receptor Blocker (ARB)
|
Inventia Healthcare Limited
|
India
|
Initial
|
18 June 2024
|
18 June 2029
|
| View |
|
DR-XY49110
|
Telmisartan
|
Telarb
|
80 mg
|
Tablet
|
Angiotensin II Receptor Blocker (ARB)
|
Inventia Healthcare Limited
|
India
|
Initial
|
18 June 2024
|
18 June 2029
|
| View |
|
DR-XY49111
|
Piperacillin (as sodium) + Tazobactam (as sodium)
|
Tazin
|
2 g/250 mg
|
Powder for Injection (I.M./I.V.)
|
Antibacterial (Penicillin/ Beta-Lactamase Inhibitor)
|
United Biotech Pvt. Ltd.
|
India
|
Initial
|
18 June 2024
|
18 June 2029
|
| View |
|
DR-XY49114
|
Hydrocortisone (as sodium succinate)
|
Succicort
|
100 mg
|
Powder for Solution for Injection (IM/IV)
|
Corticosteroid
|
VHB Medi Sciences Limited
|
India
|
Initial
|
27 June 2024
|
27 June 2029
|
| View |
|
DR-XY49118
|
Vancomycin (as hydrochloride)
|
Vansafe-CP
|
500 mg
|
Powder for Solution for Intravenous Infusion
|
Antibacterial (Glycopeptide)
|
VHB Medi Sciences Limited
|
India
|
Initial
|
28 June 2024
|
28 June 2029
|
| View |
|
DR-XY49119
|
Multivitamins + Iron
|
TLC Vita-OB
|
Formulation:
Each capsule contains:
Ascorbic Acid (Vitamin C) 100 mg
Niacinamide (Vitamin B3) 25 mg
Thiamine Mononitrate (Vitamin B1) 10 mg
Riboflavin (Vitamin B2) 10 mg
Calcium Pantothenate (Vitamin B5) 5 mg
Pyridoxine Hydrochloride (Vitamin B6) 5 mg
Folic Acid (Vitamin B9) 950 mcg
Cyanocobalamine (Vitamin B12) 25 mcg
Iron 105 mg
(equivalent to 325 mg Ferrous Fumarate)
|
Capsule
|
Vitamin/Mineral
|
La Croesus Pharma, Inc.
|
Philippines
|
Initial
|
09 July 2024
|
09 July 2029
|
| View |
|
DR-XY49120
|
Cefepime (as hydrochloride)
|
Cepiram
|
1 g
|
Powder for Injection (IM/IV)
|
Fourth-Generation Cephalosporin
|
Qilu Pharmaceutical Co. Ltd.
|
China
|
Initial
|
04 July 2024
|
04 July 2029
|
| View |
|
DR-XY49121
|
Montelukast (as sodium) + Levocetirizine
Dihydrochloride
|
Metrizine
|
10 mg/5 mg
|
Film-Coated Tablet
|
Leukotriene Receptor Antagonist and Piperazine
Derivative
|
Simpex Pharma Pvt. Ltd.
|
India
|
Initial
|
04 July 2024
|
04 July 2029
|
| View |
|
DR-XY49122
|
Telmisartan + Amlodipine (as Besilate)
|
Telmez CCB
|
80 mg/10 mg
|
Tablet
|
Angiotensin II Receptor Blocker (ARB) & Calcium
Channel Blocker
|
Ajanta Pharma Limited
|
India
|
Initial
|
05 July 2024
|
05 July 2029
|
| View |
|
DR-XY49123
|
Lactated Ringer's Solution
|
none
|
Formulation:
Each 100 mL contains:
Sodium Chloride
600 mg Sodium Lactate 320 mg
Calcium Chloride dihydrate 27 mg
Potassium Chloride
40 mg
|
Solution for Intravenous Infusion.
|
Electrolyte Replenisher
|
Shijiazhuang No. 4 Pharmaceutical Co., Ltd.
|
China
|
Initial
|
05 July 2024
|
05 July 2029
|
| View |
|
DR-XY49124
|
Tranexamic Acid
|
Sitixamic
|
500 mg/5 mL
|
Solution for Injection (I.V.)
|
Amino Acid
|
Tianjin Kingyork Group Hubei Tianyao Pharmaceutical
Co., Ltd.
|
China
|
Initial
|
05 July 2024
|
05 July 2029
|
| View |
|
DR-XY49125
|
Tramadol Hydrochloride + Paracetamol
|
Adolpan
|
37.5 mg/325 mg
|
Film-Coated Tablet
|
Opioid in Combination with Non-Opioid Analgesic
|
Pharmix Laboratories (Pvt) Ltd)
|
Pakistan
|
Initial (Reapplication)
|
05 July 2024
|
05 July 2029
|
| View |
|
DR-XY49126
|
Dexmedetomidine
|
None
|
100 mcg/mL
|
concentrate solution for IV infusion
|
Hypnotic and Sedative
|
B. Braun Medical, S.A
|
Spain
|
Initial
|
08 July 2024
|
08 July 2029
|
| View |
|
DR-XY49127
|
Sorafenib (as tosylate)
|
Alvofenib
|
200 mg
|
Film-Coated Tablet
|
Other Protein Kinase Inhibitor
|
PharOS MT Ltd..
|
Malta
|
Initial
|
09 July 2024
|
09 July 2029
|
| View |
|
DR-XY49128
|
Paracetamol + Ibuprofen (as sodium dihydrate)
|
Fasrel
|
325 mg / 200 mg
|
Tablet
|
Analgesic Antipyretic / Non-Steroidal Anti-
Inflammatory Drug (NSAID)
|
UNILAB, Inc.
|
Philippines
|
Initial
|
09 July 2024
|
09 July 2029
|
| View |
|
DR-XY49129
|
Multivitamins + Minerals + Amino Acids.
|
Revicon
|
Formulation:
Each Film-Coated Tablet contains:
Retinol Acetate (Vitamin A)
1,500 IU dL-Alpha-Tocopheryl Acetate (Vitamin E) 5 IU
Thiamine Mononitrate (Vitamin B1)
5mg
Riboflavin (Vitamin B2) 3 mg
Cyanocobalamin (Vitamin B12) 5 mcg
Pyridoxine Hydrochloride (Vitamin B1) 1.5 mg
Niacinamide 20mg
Calcium Pantothenate 10 mg
Dibasic Calcium Phosphate 100 mg
Copper (as Copper Gluconate) 1 mg
Iron (as Iron Carbonyl) 10 mg
Manganese (as Manganese Gluconate) 1.31 mg
Methionine 5 mg
Lysine (as Lysine Hydrochloride) 2.5 mg
Debittered Brewer's Yeast 25 mg
|
Film-Coated Tablet
|
Vitamins / Minerals
|
UNILAB, Inc.
|
Philippines
|
Initial
|
09 July 2024
|
09 July 2029
|
| View |
|
DR-XY49130
|
Pantoprazole
|
Panlec
|
40 mg
|
Lyophilized Powder for Injection (IV)
|
Proton Pump Inhibitor
|
Myungmoon Pharmaceutical Co., Ltd..
|
Korea
|
Initial
|
11 July 2024
|
11 July 2029
|
| View |
|
DR-XY49131
|
Pantoprazole
|
Pantokhriz 40
|
40 mg
|
Lyophilized Powder for Injection (IV)
|
Proton Pump Inhibitor
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
11 July 2024
|
11 July 2029
|
| View |
|
DR-XY49132
|
Escitalopram (as oxalate)
|
Ciklox
|
10 mg
|
Film-Coated Tablet
|
Antidepressant (Selective serotonin reuptake inhibitor)
|
Kusum Healthcare Pvt. Ltd.
|
India
|
Initial
|
11 July 2024
|
11 July 2029
|