| View |
DR-XY48548_PI_01.pdf
|
DR-XY48548
|
Sitagliptin (As Hydrochloride)
|
Sitazit 50
|
50 mg
|
Film-Coated Tablet
|
-
|
Hetero Labs Limited, Unit V
|
India
|
Monitored Release
|
29 December 2022
|
29 December 2027
|
| View |
|
DR-XY48549
|
Erlotinib (as hydrochloride
|
Riltared
|
150 mg
|
Film-Coated Tablet
|
-
|
Dr. Reddy's Laboratories Ltd. (Formulation FTO-7)
|
India
|
Initial
|
29 December 2022
|
29 December 2027
|
| View |
|
DR-XY48550
|
Risperidone
|
Rosemide
|
4 mg
|
Orodispersible Tablet
|
-
|
Kusum Healthcare Pvt. Ltd.
|
India
|
Monitored Release
|
29 December 2022
|
29 December 2027
|
| View |
|
DR-XY48551
|
Carfilzomib
|
Karpilred
|
60 mg
|
Lyophilized Powder for Solution for Injection (IV)
|
-
|
Dr. Reddy's Laboratories Ltd. (Formulation FTO-7)
|
India
|
Monitored Release
|
05 January 2023
|
05 January 2026
|
| View |
|
DR-XY48552
|
Sitagliptin (as phosphate monohydrate) + Metformin
Hydrochloride
|
Sitamac M 50/500
|
50 mg / 500 mg
|
Film-Coated Tablet
|
-
|
Macleods Pharmaceuticals Limited
|
India
|
Initial
|
05 January 2023
|
05 January 2028
|
| View |
|
DR-XY48553
|
Sitagliptin (as phosphate monohydrate) + Metformin
Hydrochloride
|
Sitamac M 50/1000
|
50 mg/1 g
|
Film-Coated Tablet
|
-
|
Macleods Pharmaceuticals Limited
|
India
|
Initial
|
05 January 2023
|
05 January 2028
|
| View |
|
DR-XY48554
|
Thiamine Mononitrate (Vitamin B1) + Pyridoxine
Hydrochloride (Vitamin B6) + Cyanocobalamin (Vitamin
B12)
|
Debion
|
100 mg / 200 mg / 200 mcg
|
Film-Coated Tablet
|
Vitamins
|
Delta Pharma Ltd.
|
Bangladesh
|
Initial (OTC)
|
06 January 2023
|
06 January 2028
|
| View |
|
DR-XY48555
|
Leflunomide
|
Lemard-20
|
20 mg
|
Film-Coated Tablet
|
Immunosuppressant
|
Ipca Laboratories Limited
|
India
|
Monitored Release (Correction)
|
26 July 2024
|
06 January 2028
|
| View |
|
DR-XY48556
|
Leflunomide
|
Lemard-10
|
10 mg
|
Film-Coated Tablet
|
Immunosuppressant
|
Ipca Laboratories Limited
|
India
|
Monitored Release (Correction)
|
30 July 2024
|
06 January 2028
|
| View |
|
DR-XY48557
|
Sevelamer Carbonate
|
Cavsamir
|
800 mg
|
Film-Coated Tablet
|
-
|
Dr. Reddy's Laboratories Limited
|
India
|
Initial
|
06 January 2023
|
06 January 2028
|
| View |
|
DR-XY48558
|
Vildagliptin
|
Vilget
|
50mg
|
Tablet
|
-
|
Getz Pharma Pvt. Ltd.
|
Pakistan
|
Initial
|
06 January 2023
|
06 January 2028
|
| View |
|
DR-XY48559
|
Dobutamine (as hydrochloride)
|
Dobutafres
|
50 mg/mL
|
Solution for IV Infusion
|
-
|
PT. Ethica Industri Farmasi (PT. Ethica)
|
Indonesia
|
Initial
|
06 January 2023
|
06 January 2028
|
| View |
DR-XY48560_PI_01.pdf
|
DR-XY48560
|
Thioctic Acid
|
Thiogamma Turboset
|
12 mg/mL (600 mg/50 mL)
|
Solution For Infusion (IV)
|
-
|
Solupharm Pharmazeutische Erzeugnisse GmbH
|
Germany
|
Monitored Release (Re-application) [Correction|
|
28 September 2023
|
18 January 2028
|
| View |
|
DR-XY48561
|
Lidocaine
|
Xylocaine
|
10 mg/0.1 mL per actuation (10% w/v)
|
Topical Spray
|
-
|
Aspen Bad Oldesloe GmbH
|
Germany
|
Initial
|
09 January 2023
|
09 January 2028
|
| View |
|
DR-XY48562
|
Piperacillin (as Sodium) + Tazobactam (as Sodium)
|
Tapimycin
|
4g/500 mg
|
Powder for Injection (IV)
|
-
|
Yung Shin Pharm. Ind. Co., Ltd. (Taichung Youth Factory III)
|
Taiwan
|
Initial
|
10 January 2023
|
10 January 2028
|
| View |
|
DR-XY48563
|
Biotin (Vitamin B7)
|
None
|
5000mcg
|
Capsules
|
-
|
Arizona Nutritional Supplements
|
United States of America
|
Initial (OTC)
|
17 January 2023
|
17 January 2028
|
| View |
|
DR-XY48564
|
Bortezomib
|
Tezomin
|
2.5 mg
|
Lyophilized Powder For Injection (IV/SC)
|
-
|
Korea United Pharm. Inc.
|
Korea
|
Initial
|
17 January 2023
|
17 January 2028
|
| View |
|
DR-XY48565
|
Erlotinib (as hydrochloride)
|
Riltared
|
100 mg
|
Film-Coated Tablet
|
-
|
Dr. Reddy's Laboratories Ltd. (Formulation FTO-7)
|
India
|
Initial
|
11 January 2023
|
11 January 2028
|
| View |
|
DR-XY48566
|
Dasatinib
|
Dasamia 140
|
140 mg
|
Film-Coated Tablet
|
Antineoplastic Agent (BCR-ABL Tyrosine Kinase Inhibitor)
|
Sun Pharma Laboratories Ltd.
|
India
|
Monitored Release (Correction)
|
05 June 2024
|
18 January 2028
|
| View |
|
DR-XY48567
|
Dasatinib
|
Dasamia 100
|
100 mg
|
Film-Coated Tablet
|
Antineoplastic Agent (BCR-ABL Tyrosine Kinase
Inhibitor)
|
Sun Pharma Laboratories Ltd.
|
India
|
Monitored Release (Correction)
|
05 June 2024
|
18 January 2028
|