| View |
|
DRP-12206
|
Telmisartan
|
Telgio
|
80 mg
|
Tablet
|
Angiotensin II Receptor Blocker
|
PT Dexa Medica
|
Indonesia
|
Initial
|
01 July 2022
|
01 July 2027
|
| View |
|
DRP-12235
|
Co-Amoxiclav
|
None
|
1 g
|
Tablet
|
Antibacterial (Penicillin and Beta-Lactamase Inhibitor)
|
Sparsh Bio-Tech Pvt., Ltd.
|
India
|
Initial
|
30 June 2022
|
30 June 2027
|
| View |
|
DRP-12222
|
Atorvastatin (As Calcium)
|
Zydusatorva 20
|
20 mg
|
Film Coated Tablet
|
HMG CoA reductase inhibitor
|
Cadila Healthcare Limited
|
India
|
Initial
|
30 June 2022
|
30 June 2027
|
| View |
|
DRP-12223
|
Atorvastatin (as Calcium)
|
Zydusatorva 10
|
10 mg
|
Film Coated Tablet
|
HMG CoA reductase inhibitor
|
Cadila Healthcare Limited
|
India
|
Initial
|
30 June 2022
|
30 June 2027
|
| View |
|
DR-XY48175
|
Vinorelbine (as tartrate)
|
Vinobin
|
20 mg
|
Softgel Capsule
|
Antineoplastic Agent (Vinca Alkaloid/Analogue)
|
Lotus Pharmaceutical Co., Ltd (Nantou Plant)
|
Taiwan
|
Initial
|
08 July 2022
|
08 July 2027
|
| View |
|
DR-XY48179
|
Fimasartan potassium + Rosuvastatin (as calcium)
|
Tuvero
|
60 mg/5 mg
|
Film-Coated Tablet
|
-
|
Boryung Pharmaceuticals Co., Ltd.
|
Korea
|
Monitored Release
|
11 July 2022
|
11 July 2025
|
| View |
|
DR-XY48180
|
Fimasartan potassium + Rosuvastatin (as calcium)
|
Tuvero
|
60 mg/10 mg
|
Film-Coated Tablet
|
-
|
Boryung Pharmaceuticals Co., Ltd.
|
Korea
|
Monitored Release
|
11 July 2022
|
11 July 2025
|
| View |
|
DR-XY48156
|
Teicoplanin
|
Ticoray
|
200mg
|
Powder For Injection (IV/IM))
|
Antibacterial
|
Mylan Laboratories Limited (Sterile Products Division)
|
India
|
Initial
|
01 July 2022
|
01 July 2027
|
| View |
|
DR-XY48161
|
Teicoplanin
|
Ticoray
|
400mg
|
Powder For Injection (IV/IM)
|
Antibacterial
|
Mylan Laboratories Limited (Sterile Products Division)
|
India
|
Initial
|
04 July 2022
|
04 July 2027
|
| View |
|
DR-XY48151
|
Emtricitabine + Tenofovir Disoproxil Fumarate
|
Teno-Em
|
200 mg/300 mg
|
Film-Coated Tablet
|
Direct Acting Antivirals (Combinations for treatment
of HIV Infections)
|
The Government Pharmaceutical Organization
|
Thailand
|
Monitored Release
|
30 June 2022
|
30 June 2027
|
| View |
DR-XY48147_PI_01.pdf
|
DR-XY48147
|
Drospirenone
|
Slinda
|
4 mg
|
Film-Coated Tablet
|
-
|
Laboratorios Leon Farma, S.A.
|
Spain
|
Monitored Release
|
30 June 2022
|
30 June 2027
|
| View |
|
DR-XY48146
|
Sildenafil (As Citrate)
|
Sildefar
|
100 mg
|
Film-Coated Tablet
|
Phosphodiesterase-5 (PDE5) Inhibitor
|
Zim Laboratories Limited
|
India
|
Initial
|
01 July 2022
|
01 July 2027
|
| View |
|
DRP-12231
|
Chloramphenicol
|
Shinacol
|
5 mg/mL (0.5% w/v)
|
Ophthalmic Solution
|
Antibacterial
|
Y.S.P. Industries (M) Sdn. Bhd
|
Malaysia
|
Initial
|
30 June 2022
|
30 June 2027
|
| View |
|
DRP-12226
|
Paracetamol
|
None
|
10 mg/mL
|
Solution For IV Infusion
|
Analgesic/Antipyretic
|
Pt. Pratapa Nirmala
|
Indonesia
|
Initial
|
01 July 2022
|
01 July 2027
|
| View |
|
DRP-12196
|
Cefotaxime (As Sodium)
|
One-Cefotaxcel
|
1 g
|
Powder For Injection (IM/IV)
|
Antibacterial (Third-generation Cephalosporin)
|
Swiss Parenterals Ltd.
|
India
|
Initial
|
01 July 2022
|
01 July 2027
|
| View |
|
DR-XY48153
|
Olmesartan Medoxomil + Amlodipine +
Hydrochlorothiazide
|
Olmat- AMH
|
40 mg/10 mg/25 mg
|
Tablets
|
Antihypertensive (Angiotensin II Receptor Blocker/ Calcium Channel Blocker/ Diuretic)
|
Micro Labs Limited
|
india
|
Monitored Release
|
01 July 2022
|
01 July 2027
|
| View |
|
DRP-12246
|
Metformin Hydrochloride
|
None
|
500 mg
|
Tablet
|
Blood glucose lowering drug (Biguanide)
|
United International Pharma Co. Ltd.
|
Vietnam
|
Initial
|
11 July 2022
|
11 July 2027
|
| View |
DR-XY48191_PI_01.pdf
|
DR-XY48191
|
Atazanavir (as sulfate)
|
None
|
200mg
|
Capsule
|
Protease Inhibitor
|
Hetero Labs Limited
|
India
|
Monitored Release
|
14 July 2022
|
14 July 2027
|
| View |
|
DRP-12245
|
Clindamycin (as hydrochloride)
|
None
|
300 mg
|
Capsule
|
Antibacterial (Macrolide)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial (Correction)
|
02 September 2022
|
02 September 2027
|
| View |
|
DRP-12315
|
Amlodipine (As Besilate)
|
Neldipin
|
10mg
|
Tablet
|
-
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial
|
13 July 2022
|
13 July 2027
|