| View |
DR-XY48835_PI_01.pdf
|
DR-XY48835
|
Cabotegravir (as sodium)
|
Apretude
|
30mg
|
Film-Coated Tablet
|
-
|
Glaxo Operations UK Limited (trading as Glaxo
Wellcome Operations
|
United Kingdom
|
Monitored Release
|
03 August 2023
|
03 August 2028
|
| View |
|
DR-XY48836
|
Meropenem (as trihydrate)
|
Meronash 1000
|
1g
|
Powder For Injection (Iv)
|
-
|
Shamshree Lifesciences Ltd.
|
India
|
Initial
|
03 August 2023
|
03 August 2028
|
| View |
|
DR-XY48837
|
Ampicillin (as sodium) + Sulbactam (as sodium)
|
Porbact-1.5
|
1 g/500 mg
|
Powder for Injection (IM/IV)
|
-
|
Med Biopharm Pvt. Ltd.
|
India
|
Initial
|
04 August 2023
|
04 August 2028
|
| View |
|
DR-XY48838
|
Ampicillin (as sodium) + Sulbactam (as sodium)
|
Porbact-750
|
500 mg/250
|
Powder for Injection (IM/IV)
|
-
|
Med Biopharm Pvt. Ltd.
|
India
|
Initial
|
04 August 2023
|
04 August 2028
|
| View |
|
DR-XY48839
|
Metformin Hydrochloride + Sitagliptin (as phosphate
monohydrate)
|
Sitaplus
|
1 g/50 mg
|
Film-Coated Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
10 August 2023
|
10 August 2028
|
| View |
|
DR-XY48840
|
Metformin Hydrochloride + Sitagliptin (as phosphate
monohydrate)
|
Sitaplus
|
500 mg/50 mg
|
Film-Coated Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
10 August 2023
|
10 August 2028
|
| View |
|
DR-XY48841
|
Rizatriptan (as Benzoate)
|
Migratan
|
10 mg
|
Tablet
|
-
|
Zydus Lifesciences Limited
|
India
|
Monitored Release
|
09 August 2023
|
09 August 2028
|
| View |
|
DR-XY48842
|
Valsartan
|
None
|
80 mg
|
Film-Coated Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
09 August 2023
|
09 August 2028
|
| View |
|
DR-XY48843
|
Telmisartan
|
Telsartin 80
|
80 mg
|
Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
10 August 2023
|
10 August 2028
|
| View |
|
DR-XY48844
|
Telmisartan + Amlodipine(as besilate)
|
Telmipin
|
80 mg/ 10 mg
|
Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
10 August 2023
|
10 August 2028
|
| View |
|
DR-XY48845
|
Levetiracetam
|
None
|
100 mg/ mL
|
Concentrate for Solution for IV Infusion
|
-
|
Mylan Laboratories Limited (Hosur Sterile Facility)
|
India
|
Initial
|
14 August 2023
|
14 August 2028
|
| View |
|
DR-XY48846
|
Telmisartan
|
Telsartin 40
|
40 mg
|
Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
14 August 2023
|
14 August 2028
|
| View |
|
DR-XY48847
|
Telmisartan + Amlodipine (As Besilate)
|
Telmipin
|
40 mg/5 mg
|
Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
14 August 2023
|
14 August 2028
|
| View |
|
DR-XY48848
|
Trimetazidine Hydrochloride
|
Angimed
|
35 mg
|
Modified Release Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial (Correction)
|
23 January 2024
|
16 August 2028
|
| View |
|
DR-XY48849
|
Sildenafil (as citrate)
|
Zilden
|
100 mg
|
Film-Coated Tablet
|
-
|
Interphil Laboratories, Inc.
|
Philippines
|
Initial
|
16 August 2023
|
16 August 2028
|
| View |
|
DR-XY48850
|
Dexamethasone phosphate (as sodium)
|
Penatone
|
4mg/mL
|
Solution for Injection (I.V./I.M.)
|
-
|
Duopharma (M) Sdn. Bhd.
|
Malaysia
|
Initial
|
17 August 2023
|
17 August 2028
|
| View |
|
DR-XY48851
|
Ascorbic Acid + Zinc+ Cholecalciferol (Vitamin D3)
|
Eovite Cdz
|
500 mg/20 mg (equivalent to 54.902 mg Zinc Sulphate
Monohydrate)/1000 IU
|
Softgel Capsule
|
-
|
Renown Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
05 September 2023
|
05 September 2028
|
| View |
DR-XY48852_PI_01.pdf
|
DR-XY48852
|
Finerenone
|
Firialta
|
10 mg
|
Film-Coated Tablet
|
-
|
Bayer AG
|
Germany
|
Monitored Release (MR)
|
23 August 2023
|
23 August 2028
|
| View |
DR-XY48853_PI_01.pdf
|
DR-XY48853
|
Finerenone
|
Firialta
|
20 mg
|
Film-Coated Tablet
|
-
|
Bayer AG
|
Germany
|
Monitored Release (MR)
|
29 August 2023
|
23 August 2028
|
| View |
|
DR-XY48854
|
Irinotecan Hydrochloride Trihydrate
|
Infuirino
|
1.5 mg/mL (270 mg/180 mL), (300 mg/200 mL),
(315 mg/210 mL), (330 mg/220 mL, (360 mg/240 mL)
|
Solution for IV Infusion
|
Antineoplastic [Topoisomerase 1 (TOP 1) inhibitor]
|
Sun Pharmaceutical Industries Limited
|
India
|
Monitored Release (Correction)
|
18 April 2024
|
24 August 2028
|