| 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-XY48181_PI_01.pdf
|
DR-XY48181
|
Lenalidomide
|
Linadex 10
|
10mg
|
Capsule
|
Immunosuppressant
|
Hetero Labs Limited (Unit-V, Block-VB)
|
India
|
Monitored Release
|
12 July 2022
|
12 July 2025
|
| View |
DR-XY48182_PI_01.pdf
|
DR-XY48182
|
Lenalidomide
|
Linadex 15
|
15mg
|
Capsule
|
Immunosuppressant
|
Hetero Labs Limited (Unit-V, Block-VB)
|
India
|
Monitored Release
|
12 July 2022
|
12 July 2025
|
| View |
|
DR-XY48183
|
Mycophenolic Acid
|
Mycofena DR
|
360 mg
|
Delayed Release Tablet
|
Immunosuppressant
|
Alkem Laboratories Limited
|
India
|
Initial
|
21 July 2022
|
21 July 2027
|
| View |
DR-XY48184_PI_01.pdf
|
DR-XY48184
|
Trifarotene
|
Aklief
|
50 mcg/g
|
Cream
|
-
|
Laboratories Galderma
|
France
|
Monitored Release
|
12 July 2022
|
12 July 2027
|
| View |
|
DR-XY48185
|
Anagrelide (as hydrochloride)
|
Anator
|
500 mcg
|
Capsule
|
Antineoplastic :
|
Torrent Pharmaceuticals Ltd.
|
India
|
Initial
|
13 July 2022
|
13 July 2027
|
| View |
|
DR-XY48186
|
Enzalutamide
|
Alvogen
|
40 mg
|
Softgel Capsule
|
-
|
Lotus Pharmaceutical Co., Ltd. (Nantou Plant)
|
Taiwan
|
Initial
|
18 July 2022
|
18 July 2027
|
| View |
|
DR-XY48187
|
Bisoprolol Fumarate
|
Bisocor
|
5 mg
|
Tablet
|
Beta blocking agents, Selective
|
Y.S.P. Industries (M) Sdn. Bhd.
|
Malaysia
|
Initial (correction)
|
30 September 2022
|
13 July 2027
|
| View |
|
DR-XY48188
|
Peritoneal Dialysis Solution with 4.25% Dextrose
|
CAPD/DPCA 18 Stay Safe Link Solution for Peritoneal
Dialysis
|
46.7g/183.8mg/101.7mg/3.925g/5.786g
|
Solution for Peritoneal
Dialysis
|
-
|
Fresenius Medical Care Production Sdn. Bhd.
|
Malaysia
|
Initial (Variation)
|
14 August 2023
|
14 August 2028
|
| View |
|
DR-XY48189
|
Amlodipine(As Besilate)
|
Amlovac
|
5mg
|
Tablet
|
Calcium Channel Blocker
|
Celogen Generics Private Ltd.
|
India
|
Initial
|
13 July 2022
|
13 July 2027
|
| View |
|
DR-XY4819
|
Guaifenesin/ Chlorphenamine Maleate/ Dextromethorphan Hbr/ Phenylpropanolamine
|
Triplec
|
50mg/ 1mg/ 10mg/ 6.25mg
|
Syrup
|
Expectorant / Centrally Acting Antitussive/ Antihistamine/ Sympathomimetic
|
Drugmakers Laboratories Inc.
|
Philippines
|
Automatic Renewal
|
08 July 2022
|
05 August 2027
|
| View |
DR-XY48190_PI_01.pdf
|
DR-XY48190
|
Atazanavir (As Sulfate)
|
Atavir 300
|
300mg
|
Capsule
|
-
|
Hetero Labs Limited
|
India
|
Monitored Release
|
14 July 2022
|
14 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 |
DR-XY48192_PI_01.pdf
|
DR-XY48192
|
Atazanavir (As Sulfate)
|
Atavir 150
|
150mg
|
Capsule
|
-
|
Hetero Labs Limited
|
India
|
Monitored Release
|
14 July 2022
|
14 July 2027
|
| View |
|
DR-XY48193
|
Apixaban
|
Thromboxain 5
|
5mg
|
Film Coated Tablet
|
Antithrombotic Agent (Direct Factor Xa Inhibitor)
|
Intas Pharmaceuticals Limited
|
India
|
Monitored Release (MR)
|
14 July 2022
|
14 July 2027
|
| View |
|
DR-XY48194
|
Apixaban
|
Thromboxain 2.5
|
2.5mg
|
Film Coated Tablet
|
Antithrombotic Agent (Direct Factor Xa Inhibitor)
|
Intas Pharmaceuticals Limited
|
India
|
Monitored Release (MR)
|
14 July 2022
|
14 July 2027
|
| View |
|
DR-XY48195
|
Mesalazine
|
Pentasa
|
2 g
|
Prolonged Release Granules
|
Prolonged - Release Granules : Intestinal Anti-inflammatory Agent (Aminosalicylic
acid/Similar Agent)
|
Ferring International Center SA
|
Switzerland
|
Monitored Release
|
15 July 2022
|
15 July 2027
|
| View |
|
DR-XY48196
|
Elobixibat (as monohydrate)
|
Goofice
|
5mg
|
Film-Coated Tablet
|
Ileal Bile Acid Transporter Inhibitor
|
EA Pharma Co., Ltd. (Fukushima Plant)
|
Japan
|
Monitored Release
|
18 July 2022
|
18 July 2027
|
| View |
|
DR-XY48197
|
Olmesartan Medoxomil + Amlodipine (As Besilate)
|
Alzor CCB
|
20mg/10mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker-Calcium
Blocker Combination
|
Ajanta Pharma Limited
|
India
|
Initial
|
18 July 2022
|
18 July 2027
|