| View |
|
DRP-12292
|
Febuxostat
|
Febuxoprim 40
|
40 mg
|
Film-Coated Tablet
|
Antigout
|
Cooper Pharma Limited
|
India
|
Initial
|
12 July 2022
|
12 July 2027
|
| View |
|
DR-XY48155
|
Ropinirole (as hydrochloride)
|
Kinetica
|
2 mg
|
Prolonged Release Tablet
|
Anti-Parkinson Drug (Dopamine Agonist)
|
Krka, D.D., Novo Mesto
|
Slovenia
|
Monitored Release
|
01 July 2022
|
01 July 2025
|
| View |
|
DR-XY48164
|
Ropinirole (as hydrochloride)
|
Kinetica
|
8 mg
|
Prolonged-Release Tablet
|
-
|
Krka, D.D., Novo Mesto
|
Slovenia
|
Monitored Release
|
04 July 2022
|
04 July 2025
|
| View |
|
DRP-12285
|
Nintendanib
|
Veganib 150
|
150 mg
|
Soft Gel Capsule
|
Antineoplastic (Protein Kinase Inhibitor)
|
Sun Pharmaceutical Industries Ltd.
|
India
|
Initial (Reconstruction)
|
03 July 2024
|
07 July 2027
|
| View |
|
DRP-12322
|
Etoricoxib
|
Bico-120
|
120 mg
|
Film-Coated Tablet
|
Non-Steroid Antiinflammatory and Antirheumatic Product
|
ACME Formulation Pvt. Ltd.
|
India
|
Initial
|
14 July 2022
|
14 July 2027
|
| View |
|
DRP-12257
|
Fenofibrate
|
Fenosaph-160
|
160 mg
|
Micronized Capsule
|
Lipid Modifying Agent (Fibrate)
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial (correction)
|
13 February 2023
|
05 July 2027
|
| View |
|
DRP-12250
|
Phospholipids + Multivitamins
|
None
|
Formulation: Each Capsule contains: Phospholipids -300 mg Riboflavin (Vitamin B2)-6mg a-Tocopheryl acetate (Vitamin E)-6mg
Nicotinamide (Vitamin B3)-30mg Thiamine mononitrate (Vitamin B1)-6mg
Pyridoxine HCl (Vitamin B6)-6 mg Cyanocobalamin (Vitamin B12)-6mcg
|
Capsule
|
Liver Therapy
|
Nabros Pharma Pvt. Ltd.
|
India
|
Initial
|
01 July 2022
|
01 July 2027
|
| View |
|
DRP-12256
|
Co-Amoxiclav
|
Co-Amoxisaph 375
|
375mg
|
Film-Coated Tablet
|
Antibacterial (Penicillin/Beta-lactamase inhibitor)
|
Sunlovis Pharmaceuticals LLP
|
India
|
Initial (Reconstruction)
|
19 January 2023
|
05 July 2027
|
| View |
|
DRP-12260
|
Fusidic Acid
|
Fusion
|
20mg/g (2% w/w)
|
Topical Cream
|
Antibacterial
|
Rhydburg Pharmaceuticals Limited
|
India
|
Initial (OTC)
|
05 July 2022
|
05 July 2027
|
| View |
|
DRP-12228
|
Folic Acid
|
Risefol
|
5 mg
|
Tablet
|
Hematinic
|
Maxtar Bio-Genics
|
India
|
Initial (OTC)
|
30 June 2022
|
30 June 2027
|
| View |
|
DR-XY48166
|
Rifampicin + Isoniazid
|
None
|
75mg/ 50mg
|
Dispersible Tablet
|
-
|
Macleods Pharmaceuticals Limited
|
India
|
Monitored Release
|
05 July 2022
|
05 July 2027
|
| View |
|
DR-XY48165
|
Rifampicin + Isoniazid
|
None
|
75mg/ 50mg
|
Dispersible Tablet
|
-
|
Macleods Pharmaceuticals Limited
|
India
|
Monitored Release
|
05 July 2022
|
05 July 2027
|
| View |
|
DRP-12253
|
Montelukast (as sodium) + Levocetirizine hydrochloride
|
None
|
10mg/5mg
|
Film Coated Tablet
|
Leukotriene Receptor Antagonist
|
Bafna Pharmaceuticals Limited
|
India
|
Initial
|
05 July 2022
|
05 July 2025
|
| View |
|
DR-XY48174
|
Daclastavir (as dihydrochloride)
|
Dacihep 60
|
60 mg
|
Film Coated Tablet
|
Direct-Acting Antiviral
|
Cadila Healthcare Limited
|
India
|
Monitored Release
|
07 July 2022
|
07 July 2027
|
| View |
|
DRP-12320
|
Co-Amoxiclav
|
Alclav
|
642.9mg/5mL
|
Powder For Suspension
|
-
|
Alkem Laboratories Limited
|
India
|
Initial
|
13 July 2022
|
13 July 2027
|
| View |
|
DRP-12230
|
Linezolid
|
Linezostad
|
600mg
|
Film-Coated Tablet
|
-
|
Hemofarm A.D.
|
Serbia
|
Initial
|
30 June 2022
|
30 June 2027
|
| View |
DR-XY48029_PI_01.pdf
|
DR-XY48029
|
Loxoprofen (as Sodium dihydrate)
|
Loxotop PAP
|
100 mg
|
Medicated Patch
|
Non-steroidal Anti-inflammatory Drug (NSAID)
|
Lead Chemical Co., Ltd. (Lead Chemical Co. Ltd.
|
Japan
|
Monitored Release
|
05 July 2022
|
05 July 2027
|
| View |
|
DR-XY48152
|
Cabergoline
|
Caberline
|
500 mcg
|
Tablet
|
Prolactine Inhibitor
|
Sun Pharmaceutical Industries Limited
|
India
|
Monitored Release (Correction)
|
26 September 2024
|
01 July 2027
|
| View |
|
DRP-12229
|
Abiraterone
|
Abiranat
|
250 mg
|
Tablet
|
-
|
Natco Pharma Limited
|
India
|
Initial (Reconstruction)
|
08 November 2022
|
30 June 2027
|
| View |
|
DRP-12205
|
Telmisartan
|
Telgio
|
40 mg
|
Tablet
|
-
|
PT Dexa Medica
|
Indonesia
|
Initial
|
01 July 2022
|
01 July 2027
|