| View |
|
DRP-11094
|
Valsartan
|
Valotens
|
80 mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker
|
PT. Dexa Medica
|
Indonesia
|
Initial
|
28 January 2022
|
28 January 2027
|
| View |
|
DR-XY 47674
|
Ursodeoxycholic Acid
|
Ursosan
|
250 mg
|
Capsule
|
-
|
PRO.MED.CS Praha A.S.
|
Czech Republic
|
-
|
25 January 2022
|
25 January 2027
|
| View |
|
DRP-11080
|
Ceftrixone (As Sodium)+ Sulbactam (As Sodium)
|
Trilactam
|
1g / 500mg
|
Powder for Injection (IM/IV)
|
Antibacterial (Cephalosporin/Beta-lactamase Inhibitor)
|
Reyoung Pharmaceutical Co. Ltd.
|
China
|
Initial
|
26 January 2022
|
26 January 2027
|
| View |
|
DRP-11058
|
Ceftriaxone (as sodium) + Sulbactam (as sodium)
|
Tamtrix
|
1 g / 500 mg
|
Powder for Injection (IM/IV)
|
Antibacterial (Cephalosporin/Beta-lactamase
Inhibitor)
|
Inject Care Parenterals Pvt. Ltd.
|
India
|
Initial
|
21 January 2022
|
21 January 2027
|
| View |
|
DRP-4296
|
Ibuprofen
|
Saphfen 200
|
200 mg
|
Tablet
|
Non-steroidal Anti-inflammatory drug/NSAID (Propionic
acid derivative)
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Automatic Renewal
|
13 March 2023
|
13 March 2028
|
| View |
DR-XY47676_PI_01.pdf
|
DR-XY47676
|
Alpelisib
|
Pivikto
|
200 mg
|
Film-Coated Tablet (200 mg Daily Dose)
|
Antineoplastic Agent [Phosphatidylinositol-3-kinase
(Pi3K) Inhibitor]
|
Novartis Pharma Stein AG
|
Switzerland
|
Monitored Release
|
20 January 2022
|
20 January 2027
|
| View |
DR-XY47677_PI_01.pdf
|
DR-XY47677
|
Alpelisib
|
Pivikto
|
250 mg + 50 mg (250 mg daily dose)
|
Film-Coated Tablet
|
Antineoplastic Agent [Phosphatidylinositol-3-kinase
(Pi3K) Inhibitor]
|
Novartis Pharma Stein AG
|
Switzerland
|
Monitored Release
|
20 January 2022
|
20 January 2027
|
| View |
DR-XY47678_PI_01.pdf
|
DR-XY47678
|
Alpelisib
|
Pivikto
|
150 mg + 150 mg (300 mg daily dose)
|
Film-Coated Tablet
|
Antineoplastic Agent [Phosphatidylinositol-3-kinase
(Pi3K) Inhibitor]
|
Novartis Pharma Stein AG
|
Switzerland
|
Monitored Release
|
20 January 2022
|
20 January 2027
|
| View |
|
DRP-11079
|
Piperacillin (as sodium) + Tazobactam (As sodium)
|
Piptavid
|
4g/500mg
|
Powder For Injection (IV)
|
Antibacterial (Piperacillin/Beta-lactamase inhibitor)
|
Zhuhai United Laboratories (Zhongshan) Co., Ltd.
|
China
|
Initial
|
26 January 2022
|
26 January 2027
|
| View |
|
DRP-11081
|
Ceftriaxone (As Sodium)
|
One-Triaxcel
|
1 g
|
Powder For Injection (IM/IV)
|
-
|
Swiss Parenterals Ltd.
|
India
|
-
|
26 January 2022
|
26 January 2027
|
| View |
|
DRP-5219-01
|
Cloxacillin (as Sodium)
|
Unbranded
|
500 mg
|
Capsule
|
Antibacterial (Beta-lactam)
|
Centurion Laboratories
(Division of Centurion Remedies Pvt. Ltd.)
|
India
|
Renewal
|
01 March 2024
|
18 February 2029
|
| View |
|
DRP-11032
|
Dolutegravir (As Sodium)
|
None
|
50 mg
|
Film Coated Tablet
|
-
|
Laurus Labs Limited (Unit II)
|
India
|
-
|
06 January 2022
|
06 January 2025
|
| View |
|
DRP-5642
|
Lansoprazole
|
Unbranded
|
30 mg
|
Delayed-Release Capsule
|
Proton Pump Inhibitor
|
Drugmaker's Laboratories Inc.
|
Philippines
|
Renewal
|
18 May 2024
|
09 September 2029
|
| View |
|
DRP-11099
|
Trimetazidine Dihydrochloride
|
None
|
35 mg
|
Modified Release Tablet
|
Anti-angina (Fatty acid oxidation (Pfox) inhibitor)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
28 January 2022
|
28 January 2027
|
| View |
|
DRP-11063
|
Warfarin Sodium
|
None
|
5 mg
|
Tablet
|
Antithrombotic
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
21 January 2022
|
21 January 2027
|
| View |
|
DRP-11104
|
Propranolol Hydrochloride
|
None
|
10 mg
|
Film-Coated Tablet
|
Non-selective Beta Blocking Agent
|
Hizon Laboratories, Inc.
|
Philippines
|
Initial
|
28 January 2022
|
28 January 2027
|
| View |
|
DR-XY47696
|
Nimodipine
|
Nimotop
|
10 mg/ 50 mL
|
Solution For Infusion (IV)
|
Calcium Channel Blocker
|
Solupharm Pharmazeutische Erzeugnisse GmbH
|
Germany
|
Initial (Correction)
|
28 January 2022
|
28 January 2027
|
| View |
|
DR-XY47686
|
Docetaxel
|
Mydoce
|
10mg/mL
|
Concentrate Solution for IV Infusion : Antineoplastic
|
Antineoplastic
|
Mylan Laboratories Limited - OTL
|
India
|
Initial
|
25 January 2022
|
25 January 2027
|
| View |
|
DRP-4293
|
Mefenamic Acid
|
Mefesaph C250
|
250 mg
|
Capsule
|
Non-steroidal Anti-inflammatory drug/NSAID
(Fenamate)
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Automatic Renewal
|
09 February 2023
|
11 March 2028
|
| View |
|
DR-XY47675
|
Ketoprofen
|
Ketotop
|
30 mg
|
Plaster
|
Non-Steroidal Anti-inflammatory and Antirheumatic
|
Handok Inc.
|
Korea
|
Initial
|
19 January 2022
|
19 January 2027
|