| View |
|
DRP-15042
|
Irbesartan + Amlodipine (as Besilate)
|
Adisart
|
300 mg/5mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker (ARB)/Calcium
Channel Blocker
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial
|
27 March 2024
|
27 March 2029
|
| View |
|
DRP-15038
|
Losartan Potassium + Amlodipine (as besilate)
|
Cardivest Plus
|
50 mg/5 mg
|
Film-Coated Tablet
|
Angiotensin II receptor blocker (ARB) and calcium channel blocker
|
Magbro Healthcare Pvt. Ltd.
|
Philippines
|
Initial
|
26 March 2024
|
26 March 2029
|
| View |
|
DR-XY49027
|
Febuxostat
|
Febulas 40
|
40 mg
|
Film-Coated Tablet
|
Anti-gout (Preparation Inhibiting Uric Acid Production)
|
Delta Pharma Ltd.
|
Bangladesh
|
Initial
|
26 March 2024
|
26 March 2029
|
| View |
|
HRP-644
|
Oral Rehydration Salts
|
SRA-ORS Lychee
|
FORMULATION
Each sachet (4.1 g) contains:
Glucose Anhydrous
2.70 g
Trisodium Citrate Dihydrate 580 mg Sodium Chloride
520 mg
Potassium Chloride
300 mg
|
Granules for Oral Solution
(Lychee Flavor)
|
Electrolytes with Carbohydrates
|
Azarias Pharmaceutical Laboratories, Inc.
|
Philippines
|
Initial
|
26 March 2024
|
26 March 2029
|
| View |
|
HRP-645
|
Oral Rehydration Salts
|
SRA-ORS Melon
|
FORMULATION
Each sachet (4.1 g) contains:
Glucose Anhydrous
2.70 g
Trisodium Citrate Dihydrate 580 mg Sodium Chloride
520 mg
Potassium Chloride
300 mg
|
Granules for Oral Solution (Melon Flavor)
|
Electrolytes with Carbohydrates
|
Azarias Pharmaceutical Laboratories, Inc.
|
Philippines
|
Initial
|
26 March 2024
|
26 March 2029
|
| View |
|
HRP-646
|
Oral Rehydration Salts
|
SRA-ORS Strawberry
|
FORMULATION
Each sachet (4.1 g) contains:
Glucose Anhydrous
2.70 g
Trisodium Citrate Dihydrate 580 mg Sodium Chloride
520 mg
Potassium Chloride
300 mg
|
Granules for Oral Solution
(Strawberry Flavor)
|
Electrolytes with Carbohydrates
|
Azarias Pharmaceutical Laboratories, Inc.
|
Philippines
|
Initial
|
26 March 2024
|
26 March 2029
|
| View |
|
DR-XY49028
|
Rivaroxaban
|
Verxaban
|
20 mg
|
Film-Coated Tablet
|
Antithrombotic Agent (Direct factor Xa inhibitor)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
26 March 2024
|
26 March 2029
|
| View |
|
DRP-15044
|
Rosuvastatin (as calcium)
|
Lipidbloc
|
10 mg
|
Film-Coated Tablet
|
Lipid Modifying Agent (HMG CoA Reductase Inhibitor)
|
Healer's Lab (Unit II)
|
India
|
Initial
|
26 March 2024
|
26 March 2029
|
| View |
|
DR-XY49017
|
Febuxostat
|
Febulas 80
|
80 mg
|
Film-Coated Tablet
|
Anti-gout (Preparation Inhibiting Uric Acid Production)
|
Delta Pharma Ltd.
|
Bangladesh
|
Initial
|
26 March 2024
|
26 March 2029
|
| View |
|
DRP-5948-02
|
Piperacillin (as sodium) + Tazobactam (as sodium)
|
Tazomin
|
4 g/500 mg
|
Powder for Injection (IM/IV)
|
Antibacterial
|
Inject Care Parenterals Pvt. Ltd.
|
India
|
Automatic Renewal (Correction)
|
29 May 2024
|
21 January 2025
|
| View |
|
DR-XY49030
|
Norepinephrine (as bitartrate monohydrate)
|
Nefrinor
|
1 mg/mL (4 mg/4 mL)
|
Solution for Infusion (I.V.)
|
Adrenergic/Dopaminergic Agent.
|
Mefar İlaç Sanayii A.Ş.
|
Turkey
|
Initial
|
27 March 2024
|
27 March 2029
|
| View |
|
DRP-15045
|
Fosfomycin (as trometamol)
|
Exelfos
|
3g
|
Granules For Oral Solution
|
Antibacterial
|
Labiana Pharmaceuticals, SLU
|
Spain
|
Initial
|
27 March 2024
|
27 March 2029
|
| View |
|
DR-XY49025
|
Sterile Water for Injection.
|
none
|
None
|
Sterile Water for Injection
|
Parenteral Diluent
|
Zhejiang Ruixin Pharmaceutical Co. Ltd.
|
China
|
Initial
|
27 March 2024
|
27 March 2029
|
| View |
|
DR-XY49026
|
Ascorbic Acid
|
Asco-C
|
250 mg/mL (500 mg/ 2 mL)
|
Solution for Injection
|
Vitamin
|
Tianjin Kingyork Group Hubei Tianyao Pharmaceutical Co., Ltd.
|
China
|
Initial
|
27 March 2024
|
27 March 2029
|
| View |
|
DRP-12424-03
|
Omeprazole (as sodium monohydrate)
|
Omepace
|
40 mg
|
Lyophilized Powder for Injection (I.V.)
|
Proton Pump Inhibitor
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
CLIDP Conversion
|
17 March 2024
|
04 August 2027
|
| View |
|
DRP-12424-04
|
Omeprazole (as sodium monohydrate)
|
Briandazole
|
40 mg
|
Lyophilized Powder for Injection (I.V.)
|
Proton Pump Inhibitor
|
Reyoung Pharmaceutical Co., Ltd
|
China
|
CLIDP Conversion
|
28 March 2024
|
04 August 2027
|
| View |
|
DRP-1272-13
|
Hydrocortisone (as sodium succinate)
|
Aecor-100
|
100 mg
|
Powder for Injection (IM/IV)
|
Corticosteroid
|
Umedica Laboratories Pvt. Ltd.
|
India
|
CLIDP Conversion
|
10 March 2024
|
07 October 2028
|
| View |
|
DRP-12788-03
|
Omeprazole
|
None
|
40 mg
|
Delayed-Release Capsule
|
Proton Pump Inhibitor
|
Sapphire Lifesciences Pvt. Ltd
|
India
|
CLIDP Conversion
|
26 March 2024
|
07 October 2027
|
| View |
|
DRP-12864-02
|
Glimepiride
|
Glimegen
|
2 mg
|
Tablet
|
Oral Hypoglycemic Agent
|
Ratnatris Pharmaceuticals Pvt. Ltd
|
India
|
CLIDP Conversion
|
10 March 2024
|
18 October 2027
|
| View |
|
DRP-12864-03
|
Glimepiride
|
Retaglim
|
2 mg
|
Tablet
|
Oral Hypoglycemic Agent
|
Ratnatris Pharmaceuticals Private Limited
|
India
|
CLIDP Conversion
|
29 March 2024
|
18 October 2027
|