| View |
|
DR-XY48855
|
Deferasirox
|
Defrijet 500
|
500 mg
|
Tablet For Oral Suspension
|
Iron chelating agent
|
Sun Pharmaceutical Industries Limited
|
India
|
Monitored Release (Reconstruction)
|
18 April 2024
|
24 August 2028
|
| View |
|
DR-XY48856
|
Sildenafil Citrate
|
Zilden
|
50 mg
|
Film-Coated Tablet
|
Phosphodiesterase Type 5 Inhibitor
|
Interphil Laboratories, Inc.
|
Philippines
|
Initial
|
23 August 2023
|
23 August 2028
|
| View |
|
DR-XY48857
|
Co-Amoxiclav
|
Spotclav Forte
|
457 mg/5 mL
|
Powder for Oral Suspension. Antibacterial (Penicillin-Beta-lactamase Inhibitor Combination)
|
Antibacterial
|
Sparsh Bio-Tech Pvt. Ltd.
|
India
|
Initial (Re-application)
|
24 August 2023
|
24 August 2028
|
| View |
|
DR-XY48858
|
Levodropropizine
|
Bronzine
|
30 mg/5 mL
|
Syrup
|
Cough Suppressant
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
30 August 2023
|
30 August 2028
|
| View |
|
DR-XY48859
|
Beclometasone diproprionate + dihydrate Glycopyrronium bromide.
|
Trimbow
|
200 mcg/ 6 mcg/ 12.5 mcg per actuation
|
Metered Dose Inhaler
|
Adrenergic-Corticosteroid-Anticholinergic Combination
|
Chiesi Farmaceutici S.p.A.
|
Italy
|
Monitored Release
|
24 August 2023
|
24 August 2028
|
| View |
|
DR-XY48860
|
Cyclophosphamide
|
Neonco
|
1g
|
Powder for Injection (I.V.)
|
Antineoplastic Agent
|
Shilpa Medicare Limited Unit 4 Pharmaceutical
Formulations Sez
|
India
|
Initial
|
01 August 2024
|
31 July 2029
|
| View |
|
DR-XY48861
|
Telmisartan
|
Telmizart
|
40 mg
|
Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
31 August 2023
|
31 August 2028
|
| View |
|
DR-XY48862
|
Telmisartan + Amlodipine (as besilate)
|
Besylon Plus
|
40 mg/5 mg
|
Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
31 August 2023
|
31 August 2028
|
| View |
|
DR-XY48863
|
Meropenem (as trihydrate)
|
Meroz
|
1g
|
Powder for Injection (I.V.)
|
Antibacterial (Carbapenem)
|
Dongkwang Pharm. Co., Ltd
|
Korea
|
Initial
|
31 August 2023
|
31 August 2028
|
| View |
|
DR-XY48864
|
Morphine Sulfate
|
Morpizol
|
10mg/mL
|
Solution for Injection (IM/IV/SC)
|
-
|
Pharmaniaga Lifesciences Sdn. Bhd.
|
Malaysia
|
Initial
|
14 September 2023
|
14 September 2028
|
| View |
|
DR-XY48865
|
Cefotaxime (as sodium)
|
Emixon
|
1g
|
Powder for Injection (IM/IV)
|
Antibacterial (Cephalosporin
|
Vellinton Healthcare
|
India
|
Initial
|
04 September 2023
|
04 September 2028
|
| View |
|
DR-XY48866
|
Caspofungin (as acetate)
|
Caspin
|
70mg
|
Powder for Concentrate for Solution for IV Infusion
|
-
|
Jiangsu Henrui Medicine Co., Ltd
|
China
|
Initial
|
05 September 2023
|
05 September 2028
|
| View |
|
DR-XY48867
|
Cefoperazone (as sodium) + Sulbactam (as sodium)
|
C-Bactum
|
1 g
|
Powder for Injection (IV/IM)
|
-
|
VHB Medi Sciences Ltd
|
India
|
Initial
|
06 September 2023
|
06 September 2028
|
| View |
|
DR-XY48868
|
Colecalciferol
|
D-Rize
|
800 IU
|
Softgel Capsule
|
-
|
Softgel Healthcare Pvt. Ltd.
|
India
|
Initial [OTC
|
06 September 2023
|
06 September 2025
|
| View |
|
DR-XY48869
|
Cholecalciferol
|
D-Rize
|
1000 IU
|
Softgel Capsule
|
-
|
Softgel Healthcare Pvt. Ltd.
|
India
|
Initial [OTC]
|
06 September 2023
|
06 September 2025
|
| View |
|
DR-XY48870
|
Fenofibrate
|
Macfibrate 145
|
145 mg
|
Film-Coated Tablet
|
-
|
Macleods Pharmaceuticals Limited
|
India
|
Initial
|
12 September 2023
|
12 September 2028
|
| View |
|
DR-XY48871
|
Netarsudil (as mesylate) + Latanoprost
|
Rocklatan
|
200 mcg/50 mcg per mL (0.02%/0.005%)
|
Ophthalmic
Solution
|
-
|
Aerie Pharmaceuticals Ireland Limited
|
Ireland
|
Monitored Release
|
06 September 2023
|
06 September 2028
|
| View |
|
DR-XY48872
|
Aluminum Hydroxide + Magnesium Hydroxide +
Simethicone
|
Khriztacid
|
200mg/100mg/25mg
|
Tablet
|
-
|
Merit Organics Ltd
|
India
|
Initial [OTC]
|
08 September 2023
|
08 September 2028
|
| View |
|
DR-XY48873
|
D-Alpha Tocopherol (Vitamin E)
|
Vigen-E
|
400 I.U
|
Softgel Capsule.
|
-
|
The ACME Laboratories, Ltd.
|
Bangladesh
|
Initial [OTC]
|
08 September 2023
|
08 September 2028
|
| View |
|
DR-XY48874
|
Iron Sucrose (as Ferric Hydroxide Sucrose Complex)
|
Porsrose
|
20 mg/mL (100 mg/5 mL)
|
Solution for Injection (IV)
|
-
|
Med Biopharm Pvt. Ltd.
|
India
|
Initial
|
12 September 2023
|
12 September 2028
|