| View |
|
DRP-15516
|
Febuxostat
|
Febuzen 80
|
80 mg
|
Film-Coated Tablet
|
Antigout Preparation
|
Akriti Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
30 July 2024
|
30 July 2029
|
| View |
|
DRP-15493
|
Albendazole
|
Amzol
|
400 mg
|
Chewable Tablet
|
Anthelmintic
|
Globela Pharma Private Limited
|
India
|
Initial
|
30 July 2024
|
30 July 2029
|
| View |
|
DRP-15545
|
Cefaclor (as monohydrate)
|
Cefakor
|
250 mg/5 mL
|
Powder for Oral Suspension (Strawberry
Flavor)
|
Antibacterial (Cephalosporin)
|
Baroque Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
31 July 2024
|
31 July 2029
|
| View |
|
DRP-15544
|
Cefaclor (as monohydrate)
|
Cefakor
|
125 mg/5 mL
|
Powder for Oral Suspension (Strawberry
Flavor)
|
Antibacterial (Cephalosporin)
|
Baroque Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
31 July 2024
|
31 July 2029
|
| View |
|
DR-XY49142
|
Clopidogrel (as bisulfate)
|
Platexan
|
75 mg
|
Film-Coated Tablet
|
Antithrom botic Agent (Platelet aggregation inhibitor incl. heparin)
|
Samjin Pharmaceutical Co., Ltd.
|
Korea
|
Initial
|
30 July 2024
|
30 July 2029
|
| View |
|
DR-XY49146
|
Paclitaxel
|
Paxus
|
6 mg/mL (100 mg/16.7mL)
|
Concentrate Solution for IV Infusion
|
Antineoplastic
|
PT Global Onkolab Farma
|
Indonesia
|
Initial
|
31 July 2024
|
31 July 2026
|
| View |
|
DRP-15532
|
Paclitaxel
|
Macrotaxel
|
6 mg/mL (30 mg/5 mL)
|
Concentrate Solution for IV
|
Antineoplastic
|
Venus Remedies Limited
|
India
|
Initial
|
31 July 2024
|
31 July 2029
|
| View |
|
DRP-15480
|
Pregabalin
|
Maxgalin 150
|
150 mg
|
Capsule
|
Antiepileptic
|
Sun Pharmaceutical Industries Limited
|
India
|
Initial
|
31 July 2024
|
31 July 2029
|
| View |
|
DR-XY49147
|
Levofloxacin (as hemihydrate)
|
Levores
|
5 mg/mL (750 mg/15 mL)
|
Solution for IV Infusion.
|
Antibacterial (Fluoroquinolone)
|
PT. Novell Pharmaceutical Laboratories
|
Indonesia
|
Initial
|
31 July 2024
|
31 July 2029
|
| View |
|
DRP-15534
|
Losartan Potassium
|
Losarx 50
|
50 mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker (ARB)
|
Globela Pharma Pvt. Ltd.
|
India
|
Initial
|
31 July 2024
|
31 July 2029
|
| View |
|
DRP-15533
|
Losartan Potassium
|
Losarx 100
|
100 mg
|
Film-Coated Tablets
|
Angiotensin II Receptor Blocker (ARB)
|
Globela Pharma Pvt. Ltd.
|
India
|
Initial
|
31 July 2024
|
31 July 2029
|
| View |
|
DRP-15540
|
Bendamustine Hydrochloride
|
Saphmustin
|
100 mg
|
Lyophilized Powder For Concentrate For I.V. Infusion
|
Antineoplastic (Alkylating Agent)
|
Bruck Pharma Private Limited
|
India
|
Initial (Rx)
|
31 July 2024
|
31 July 2029
|
| View |
|
DRP-15521
|
Azithromycin (as dihydrate)
|
Blizeth 500 T
|
500 mg
|
Film-Coated Tablet
|
Antibacterial (Macrolide)
|
Next Wave (India)
|
India
|
Initial
|
31 July 2024
|
31 July 2029
|
| View |
|
DRP-15536
|
Tranexamic acid
|
Trenaxin
|
500 mg/5 mL (100 mg/mL)
|
Solution for Intravenous
|
Antifibrinolytic (Amino acid)
|
Y.S.P. Industries (M) Sdn. Bhd.
|
Malaysia
|
Initial (Correction)
|
18 September 2024
|
31 July 2029
|
| View |
|
DRP-15539
|
Acyclovir (as sodium)
|
Clovirasi
|
250 mg
|
Powder for Injection
|
Antiviral
|
Indasi Lifesciences Pvt. Ltd.
|
India
|
Initial (Rx)
|
31 July 2024
|
31 July 2029
|
| View |
|
DRP-15520
|
Azithromycin (as dihydrate)
|
Throinfec DS
|
200 mg/5 mL
|
Powder for Oral Suspension
|
Antibacterial (Macrolide)
|
S Kant Healthcare Limited
|
India
|
Initial
|
31 July 2024
|
31 July 2029
|
| View |
|
DRP-15526
|
Atorvastatin (as calcium trihydrate)
|
Sunvas 10
|
10 mg
|
Film-Coated Tablet
|
Lipid Modifying Agent (HMG
Inhibitor)
|
Sun Pharmaceutical Industries Limited
|
India
|
Initial
|
31 July 2024
|
31 July 2029
|
| View |
|
DRP-15525
|
Atorvastatin (as calcium trihydrate)
|
Sunvas 20
|
20 mg
|
Film-Coated Tablet
|
Lipid Modifying Agent (HMG CoA
Inhibitor)
|
Sun Pharmaceutical Industries Limited
|
India
|
Initial
|
31 July 2024
|
31 July 2029
|
| View |
|
DRP-15524
|
Atorvastatin (as calcium trihydrate)
|
Sunvas 40
|
40 mg
|
Film-Coated Tablet
|
Hmg-Coa-Reductase Inhibitor
|
Sun Pharmaceutical Industries Limited
|
India
|
Initial
|
31 July 2024
|
31 July 2029
|
| View |
|
DRP-15523
|
Atorvastatin (as calcium trihydrate)
|
Sunvas 80
|
80 mg
|
Film-Coated Tablet
|
Lipid Modifying Agent (HMG
Inhibitor)
|
Sun Pharmaceutical Industries Limited
|
India
|
Initial
|
31 July 2024
|
31 July 2029
|