| View |
|
DRP-13041
|
Fluconazole
|
Fungisaph
|
2 mg/mL (200 mg/100 mL)
|
Solution for IV Infusion
|
-
|
Jedux Parenteral Private Limited
|
India
|
Initial
|
22 November 2022
|
22 November 2027
|
| View |
|
DRP-13050
|
Furosemide
|
Urinasaph-F20
|
10 mg/mL (20 mg/ 2 mL)
|
Solution For Injection (IM/IV)
|
-
|
Kilitch Drugs (India) Ltd.
|
India
|
Initial
|
22 November 2022
|
22 November 2027
|
| View |
|
DRP-13043
|
Mupirocin
|
Barozin
|
20 mg/g (2% w/w)
|
Ointment
|
-
|
Nanz Med Science Pharma Pvt. Ltd.
|
India
|
Initial
|
24 November 2022
|
24 November 2027
|
| View |
DR-XY48494_PI_01.pdf
|
DR-XY48494
|
Ondansetron (as hydrochloride dihydrate)
|
Frenvo
|
4 mg/5 mL
|
Syrup
|
-
|
Delpharm Bladel B.V.
|
Netherlands
|
Monitored Release
|
25 November 2022
|
25 November 2027
|
| View |
|
DR-XY48506
|
Digoxin
|
Lanoxin
|
250 mcg/mL (500 mcg/2mL)
|
Solution For Injection
|
-
|
Cenexi
|
France
|
Initial (correction)
|
10 February 2023
|
28 November 2027
|
| View |
|
DR-XY48496
|
Deferasirox
|
Defetor 250
|
250 mg
|
Dispersible Tablet
|
-
|
Torrent Pharmaceuticals Ltd.
|
India
|
Initial
|
25 November 2022
|
25 November 2027
|
| View |
|
DR-XY48497
|
Deferasirox
|
Defetor 125
|
125mg
|
Dispersible Tablet
|
-
|
Torrent Pharmaceuticals Ltd.
|
India
|
Initial
|
25 November 2022
|
25 November 2027
|
| View |
|
DR-XY48495
|
Deferasirox
|
Defetor 500
|
500 mg
|
Dispersible Tablet
|
-
|
Torrent Pharmaceuticals Ltd.
|
India
|
Monitored Release
|
25 November 2022
|
25 November 2027
|
| View |
|
DRP-13085
|
Xuric 80
|
Febuxostat
|
80mg
|
Film-Coated Tablet
|
Antigout
|
Globela Pharma Private Limited
|
India
|
Initial
|
28 November 2022
|
28 November 2027
|
| View |
|
DR-XY48488
|
Entecavir (as Monohydrate)
|
Envira 0.5
|
500 mcg
|
Film Coated Tablet
|
-
|
Unison Laboratories Co., Ltd.
|
Thailand
|
Initial
|
23 November 2022
|
23 November 2027
|
| View |
|
DR-XY48487
|
Entecavir (as Monohydrate)
|
Envira 1
|
1 mg
|
Film Coated Tablet
|
-
|
Unison Laboratories Co., Ltd.
|
Thailand
|
Initial
|
23 November 2022
|
23 November 2027
|
| View |
DR-XY48503_PI_01.pdf
|
DR-XY48503
|
Tafenoquine (as Succinate)
|
Kozenis
|
150mg
|
Film-coated tablet
|
-
|
Piramal Enterprises Limited
|
India
|
Monitored Release
|
25 November 2022
|
25 November 2025
|
| View |
|
DRP-13052
|
Lidocaine Hydrochloride
|
Blesanumb
|
10 mg/mL (1%w/v)
|
Solution For Injection (IM/IV)
|
-
|
Makcur Laboratories Limited
|
India
|
Initial
|
23 November 2022
|
23 November 2027
|
| View |
DR-XY48493_PI_01.pdf
|
DR-XY48493
|
Lenalidomide
|
Lenzest 10
|
10 mg
|
Capsule
|
Immunosuppressant
|
Sun Pharmaceuticals Industries Ltd.
|
India
|
Monitored Release (Reconstruction)
|
27 June 2024
|
25 November 2027
|
| View |
DR-XY48492_PI_01.pdf
|
DR-XY48492
|
Lenalidomide
|
Lenzest 25
|
25 mg
|
Capsule
|
Immunosuppressant
|
Sun Pharmaceutical Industries Limited
|
India
|
Monitored Release (Reconstruction)
|
24 May 2024
|
25 November 2027
|
| View |
|
DRP-13053
|
Vildagliptin
|
Vizlix
|
50 mg
|
Tablet
|
-
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial
|
23 November 2022
|
23 November 2027
|
| View |
|
DRP-13077
|
Ursodeoxycholic Acid
|
Odiol 250
|
250mg
|
Film-Coated Tablet
|
-
|
Globela Pharma Private Limited
|
India
|
Initial
|
25 November 2022
|
25 November 2027
|
| View |
|
DRP-13079
|
Guaifenesin + Bromhexine Hydrochloride + Salbutamol (as Sulfate)
|
Salbuxine
|
100mg/4mg/2mg per 10mL
|
Syrup
|
Expectorant / Mucolytic / Bronchodilator
|
Drugmaker's Laboratories, Inc.
|
Philippines
|
Renewal
|
10 June 2024
|
25 November 2029
|
| View |
|
DRP-13086
|
Febuxostat
|
Xuric 40
|
40mg
|
Film-Coated Tablet
|
-
|
Globela Pharma Private Limited
|
India
|
Initial
|
28 November 2022
|
28 November 2027
|
| View |
|
DRP-13076
|
Ursodeoxycholic Acid
|
Odiol 500
|
500mg
|
Film-Coated Tablet
|
-
|
Globela Pharma Private Limited
|
India
|
Initial
|
25 November 2022
|
25 November 2027
|