| View |
|
DRP-15081
|
Topiramate
|
Topirol 25
|
25 mg
|
Film-Coated Tablet
|
Antiepileptic
|
Sun Pharmaceutical Industries Limited
|
India
|
Initial
|
17 April 2024
|
17 April 2029
|
| View |
|
DRP-15080
|
Topiramate
|
Topirol 50
|
50 mg
|
Film-Coated Tablet
|
Antiepileptic
|
Sun Pharmaceutical Industries Limited
|
India
|
Initial
|
17 April 2024
|
17 April 2029
|
| View |
|
DR-XY49049
|
Sterile Water for Irrigation.
|
Klean & Kare
|
None
|
None
|
None
|
A.N.B. Laboratories Co., Ltd.
|
Thailand
|
Initial
|
17 April 2024
|
17 April 2029
|
| View |
|
DRP-15077
|
Vildagliptin + Metformin Hydrochloride.
|
DIPP-4 Plus
|
50 mg/ 850 mg
|
Film-Coated Tablet
|
Oral Hypoglycemic Agent
(Dipeptidyl Peptidase-4 Inhibitor + Biguanide)
|
Bafna Pharmaceuticals Limited
|
India
|
Initial
|
17 April 2024
|
17 April 2029
|
| View |
|
DRP-15085
|
Rosuvastatin (as calcium) + Fenofibrate
|
Fibros
|
10 mg/160 mg
|
Film-Coated Tablet
|
Lipid Modifying Agent, Combination
|
Mepro Pharmaceuticals Private Limited
|
India
|
Initial
|
17 April 2024
|
17 April 2029
|
| View |
|
DRP-15086
|
Rosuvastatin (as calcium) + Fenofibrate
|
None
|
20 mg/160 mg
|
Film-Coated Tablet
|
Lipid Modifying Agent, Combination
|
Mepro Pharmaceuticals Private Limited
|
India
|
Initial
|
17 April 2024
|
17 April 2029
|
| View |
|
DRP-15083
|
Rosuvastatin (as calcium) + Fenofibrate
|
Fibros
|
20 mg/160 mg
|
Film-Coated Tablet
|
Lipid Modifying Agent, Combination.
|
Mepro Pharmaceuticals Private Limited
|
India
|
Initial
|
17 April 2024
|
17 April 2029
|
| View |
|
DRP-15084
|
Cisplatin
|
Cis Spal-L 50
|
1 mg/mL (50 mg/50 mL)
|
Concentrate Solution for IV Infusion
|
Antineoplastic (Platinum Compound)
|
SP Accure Labs., Pvt. Ltd
|
India
|
Initial
|
17 April 2024
|
17 April 2029
|
| View |
|
DRP-15088
|
Aciclovir
|
Hexavir
|
50 mg/g (5% w/w)
|
Topical Cream
|
Antiviral
|
Front Pharmaceutical PLC
|
China
|
Initial
|
18 April 2024
|
18 April 2029
|
| View |
|
DRP-15087
|
Dexamethasone +
Tobramycin
|
Dexatobrin
|
1 mg/3 mg per mL (0.1 % 0.3% w/v)
|
Sterile Ophthalmic Ointment
|
Corticosteroid-Antiinfective Combination
|
Egyptian International Pharmaceutical Industries Co.,
|
Egypt
|
Initial
|
18 April 2024
|
18 April 2029
|
| View |
|
DRMO-102
|
Medical Grade Oxygen
|
None
|
None
|
None
|
Medical Gas
|
Dewan Trading
|
Philippines
|
Initial Rx
|
17 April 2024
|
17 April 2029
|
| View |
|
DR-XY49051
|
Ticagrelor
|
Tigemac 90
|
90 mg
|
Film-Coated Tablet
|
Platelet Aggregation Inhibitor Excl. Heparin
|
Macleods Pharmaceuticals Limited
|
India
|
Initial
|
17 April 2024
|
17 April 2029
|
| View |
|
DRP-14654
|
Captopril
|
Captivo 25
|
25 mg
|
Tablet
|
Angiotensin Converting Enzyme (ACE) Inhibitor
|
Globela Pharma Private Limited
|
India
|
Initial
|
17 April 2024
|
17 April 2029
|
| View |
|
DR-XY49053
|
Lisinopril (as dihydrate)
|
Zestril
|
10 mg
|
Tablet
|
Angiotensin-Converting Enzyme (ACE) Inhibitor
|
Rovi Pharma Industrial Services, S.A.
|
Spain
|
Initial
|
17 April 2024
|
17 April 2029
|
| View |
|
DR-XY49054
|
Lisinopril (as dihydrate)
|
Zestril
|
20 mg
|
Tablet
|
Angiotensin-Converting Enzyme (ACE) Inhibitor
|
Rovi Pharma Industrial Services, S.A.
|
Spain
|
Initial
|
17 April 2024
|
17 April 2029
|
| View |
|
DR-XY49055
|
Amlodipine (as besilate) + Olmesartan medoxomil
|
Olmesar-AM 10/40
|
10 mg/40 mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker and Calcium Channel
Blocker
|
Hetero Labs Limited (Unit V)
|
India
|
Initial
|
17 April 2024
|
17 April 2029
|
| View |
|
DRMO-103
|
Medical Grade Oxygen
|
None
|
None
|
None
|
Medical Gas
|
ORO Oxygen Corporation
|
Philippines
|
Initial Rx
|
17 April 2024
|
17 April 2029
|
| View |
|
DRMO-104
|
Medical Grade Oxygen
|
None
|
None
|
None
|
Medical Gas
|
ORO Oxygen Corporation
|
Philippines
|
Initial Rx
|
17 April 2024
|
17 April 2029
|
| View |
|
DR-XY49052
|
Lisinopril (as dihydrate)
|
Zestril
|
5 mg
|
Tablet
|
Angiotensin-Converting Enzyme (ACE) Inhibitor
|
Rovi Pharma Industrial Services, S.A.
|
Spain
|
Initial
|
17 April 2024
|
17 April 2029
|
| View |
|
DRP-15079
|
Topiramate
|
Topirol 100
|
100 mg
|
Film-Coated Tablet
|
Antiepileptic
|
Sun Pharmaceutical Industries Limited
|
India
|
Initial
|
17 April 2024
|
17 April 2029
|