| View |
|
DRP-15410
|
Thiamazole
|
Thymaz
|
20 mg
|
Tablet
|
Antithyroid
|
Novagen Healthcare Private 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 |
|
DRP-15408
|
Amlodipine (as besilate) + Valsartan
|
Avazart
|
5mg/160mg
|
Film-Coated Tablet
|
Antihypertensive
|
Healer's Lab (Unit II)
|
India
|
Initial
|
04 July 2024
|
04 July 2029
|
| View |
|
DRP-15409
|
Amlodipine (as besilate) + Valsartan
|
Avazart
|
5mg/80mg
|
Film-Coated Tablet
|
Antihypertensive
|
Healer's Lab (Unit II)
|
India
|
Initial
|
04 July 2024
|
04 July 2029
|
| View |
|
DRP 15387
|
Linagliptin
|
Krijenta
|
5 mg
|
Tablet
|
Blood Glucose Lowering Drug
|
Fredun Pharmaceuticals Ltd.
|
India
|
Initial (Reapplication)
|
03 July 2024
|
03 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-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 |
|
DRP-15414
|
Esomeprazole (as magnesium trihydrate)
|
None
|
20 mg
|
Enteric-Coated Tablet
|
Proton Pump Inhibitor
|
Lee Pharma Limited.
|
India
|
Initial (Re-Application)
|
05 July 2024
|
05 July 2029
|
| View |
|
DRP-15418
|
Moxifloxacin (as hydrochloride)
|
Moxiquin
|
400 mg/100 mL
|
Solution for IV Infusion
|
Fluoroquinolone
|
BML Parenteral Drugs
|
India
|
Initial
|
05 July 2024
|
05 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 |
|
DRP-15429
|
Dapagliflozin (as propanediol monohydrate)
|
Daphix
|
10 mg
|
Film Coated Tablet
|
Sodium-glucose co-transporter 2 (SGLT2) Inhibitor
|
Exemed Pharmaceuticals
|
India
|
Initial
|
08 July 2024
|
08 July 2029
|
| View |
|
DRP-15430
|
Oxaliplatin
|
Oxaliget
|
2 mg/mL (50 mg/25 mL)
|
Solution for IV Infusion.
|
Antineoplastic Agent
|
Venus Remedies Limited
|
India
|
Initial
|
08 July 2024
|
08 July 2029
|
| View |
|
DRP - 15390
|
Betamethasone
|
None
|
1 mg/g (0.1% w/w)
|
Cream
|
Topical Corticosteroid
|
Azine Healthcare Pvt. Ltd.
|
India
|
Initial
|
02 July 2024
|
02 July 2029
|
| View |
|
DRP-15401
|
Lactated Ringer's Solution
|
Axaring-RL
|
Formulation:
Each 100 mL contains:
Sodium Lactate
320 mg
Calcium Chloride dihydrate 27 mg
Potassium Chloride
40 mg
Sodium Chloride
600 mg
|
Solution for Intravenous Infusion.
|
Electrolyte Replenisher
|
Axa Parenterals Ltd.
|
India
|
Initial
|
03 July 2024
|
03 July 2029
|
| View |
|
DRP-15351
|
Tranexamic Acid
|
Hemovee
|
100 mg/mL (500mg/5mL)
|
Solution for Injection (I.M./I.V.)
|
Anti-Fibrinolytic
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
03 July 2024
|
03 July 2029
|
| View |
|
DRP-15395
|
Moxifloxacin (as Hydrochloride)
|
Florqin
|
5 mg/mL (0.5% w/v)
|
Ophthalmic Solution (Eye Drops)
|
Antibacterial (Fluoroquinolone)
|
Swiss Parenterals Ltd. (Block-B)
|
India
|
Initial
|
03 July 2024
|
03 July 2029
|
| View |
|
DRP-15046
|
Atorvastatin (as calcium trihydrate)
|
Atorimax-80
|
80 mg
|
Film-Coated Tablet
|
Lipid Modifying Agent (HMG CoA Reductase
Inhibitor)
|
Healer's Lab (Unit II)
|
India
|
Initial
|
03 July 2024
|
03 July 2029
|
| View |
|
DRP-15407
|
Amlodipine (as besilate) + Valsartan
|
Avazart
|
10mg/160mg
|
Film-Coated Tablet
|
Antihypertensive
|
Healer's Lab (Unit II)
|
India
|
Initial
|
03 July 2024
|
03 July 2029
|
| View |
|
DRP-15313
|
Iron Sucrose (as Ferric Hydroxide Sucrose Complex)
|
Iroxari
|
20 mg/mL (100 mg/5 mL)
|
Solution for I.V. Injection
|
Anti-anemic preparation
|
Pharmax India Private Limited
|
India
|
Initial
|
02 July 2024
|
02 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
|