| View |
|
DRP-12194
|
Co-Amoxiclav
|
Elmox-CV 457
|
457 mg/5 mL
|
Powder for Oral Suspension
|
Antibacterial (Penicillin)
|
Yeluri Formulations Pvt. Ltd.
|
India
|
Initial
|
28 June 2022
|
28 June 2027
|
| View |
|
DRP-12193
|
Diosmin + Hesperidin
|
Diorect
|
450 mg/ 50 mg
|
Tablet
|
Vasoprotective
|
Sun Pharmaceutical Industries Limited
|
India
|
Initial (Reconstruction)
|
24 May 2024
|
28 June 2027
|
| View |
|
DR-XY48118
|
Escitalopram (as Oxalate)
|
Depram
|
10 mg
|
Film Coated Tablet
|
Antidepressant (Selective Serotonin Reuptake Inhibitor)
|
PT. Novell Pharmaceutical Laboratories
|
Indonesia
|
Initial
|
22 June 2022
|
22 June 2027
|
| View |
DR-XY48143_PI_01.pdf
|
DR-XY48143
|
Valproic Acid
|
Depakene
|
250mg/5mL
|
Syrup
|
-
|
P.T. Abbott Indonesia
|
Indonesia
|
Initial
|
28 June 2022
|
28 June 2027
|
| View |
|
DRP-12136
|
Atorvastatin (As Calcium trihydrate)
|
Avamax
|
10 mg
|
Film-Coated Tablet
|
-
|
PT Darya-Varia Laboratoria, Tbk.
|
Indonesia
|
Initial
|
22 June 2022
|
22 June 2027
|
| View |
|
DRP-12135
|
Atorvastatin (As Calcium trihydrate)
|
Avamax
|
20 mg
|
Film-Coated Tablet
|
-
|
PT Darya-Varia Laboratoria, Tbk.
|
Indonesia
|
Initial
|
20 June 2022
|
20 June 2027
|
| View |
|
DRP-12134
|
Atorvastatin (As Calcium trihydrate)
|
Avamax
|
40 mg
|
Film-Coated Tablet
|
HMG CoA reductase inhibitors
|
PT Darya-Varia Laboratoria, Tbk.
|
Indonesia
|
Initial
|
20 June 2022
|
20 June 2027
|
| View |
|
DRP-12155
|
Atorvastatin(as Calcium Trihydrate)
|
Atormed-20
|
20mg
|
Film Coated Tablet
|
-
|
ACME Formulations Pvt. Ltd.
|
India
|
Initial
|
22 June 2022
|
22 June 2027
|
| View |
|
DR-XY48120
|
Olmesartan medoxomil + Hydrochlorothiazide
|
Alzor HCT
|
40mg/12.5mg
|
Film-Coated Tablet
|
-
|
Ajanta Pharma Limited
|
India
|
Initial
|
21 June 2022
|
21 June 2027
|
| View |
|
DR-XY48121
|
Olmesartan medoxomil + Hydrochlorothiazide
|
Alzor HCT
|
20mg/ 12.5mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker/Diuretic
|
Ajanta Pharma Limited
|
India
|
Initial
|
21 June 2022
|
21 June 2027
|
| View |
|
DRP-12160
|
Aceclofenac
|
Aceclomed
|
100 mg
|
Film-Coated Tablet
|
Non-Steroidal Anti-Inflammatory Drug (NSAID)
|
Acme Formulation Pvt. Ltd.
|
India
|
Initial
|
24 June 2022
|
24 June 2027
|
| View |
|
DR-XY48135
|
Azathioprine
|
Imuran
|
50 mg
|
Tablet
|
Immunosuppressant
|
Aspen SA Operations (Pty) Ltd.
|
Africa
|
Initial
|
24 June 2022
|
24 June 2027
|
| View |
|
DRP-12151
|
Dutasteride
|
None
|
500 mcg
|
Softgel Capsule
|
5a-Reductase Inhibitor
|
Cyndea Pharma S.L.
|
Spain
|
Initial
|
21 June 2022
|
21 June 2027
|
| View |
|
DRP-12158
|
Sildenafil (as citrate)
|
None
|
50 mg
|
Film-Coated Tablet
|
-
|
Diamond Laboratories Inc.
|
Philippines
|
Initial
|
24 June 2022
|
24 June 2027
|
| View |
|
DR-XY44307
|
Doripenem (as monohydrate)
|
Drofepen
|
500 mg
|
Powder for Intravenous Infusion
|
Antibacterial (Carbapenem)
|
Mepromax Lifesciences Pvt. Ltd.
|
India
|
Initial (from Monitored Release)
|
27 June 2022
|
11 March 2025
|
| View |
|
DRP-12150
|
Cefoxitin (As Sodium)
|
One-Cefoxcel
|
1 g
|
Powder for Injection (IV)
|
Antibacterial (Cephalosporin)
|
Swiss Parenterals Ltd.
|
India
|
Initial
|
22 June 2022
|
22 June 2027
|
| View |
|
DRP-12182
|
Meropenem (As Trihydrate)
|
Myrronem
|
500mg
|
Powder for Injection (IV)
|
Antibacterial (Carbapenem)
|
CSPC Ouyi Pharmaceutical Co., Ltd.
|
China
|
Initial
|
27 June 2022
|
27 June 2027
|
| View |
|
DRP-12183
|
Meropenem (as trihydrate)
|
Myrronem
|
1 g
|
Powder for Injection (IV)
|
Antibacterial (Carbapenem)
|
CSPC Ouyi Pharmaceutical Co., Ltd.
|
China
|
Initial
|
27 June 2022
|
27 June 2027
|
| View |
|
DRP-12055
|
Silver Sulfadiazine
|
Flamavid
|
10 mg/g (1% w/w)
|
Topical Cream
|
Chemotherapeutic for Topical Use (Sulfonamide)
|
Winston Medical Supply Co., Ltd.
|
China
|
Initial
|
27 June 2022
|
27 June 2027
|
| View |
|
DRP-12054
|
Silver Sulfadiazine
|
Flamavid
|
10 mg/g (1% w/w)
|
Topical Cream
|
Chemotherapeutic for Topical Use (Sulfonamide)
|
Winston Medical Supply Co., Ltd.
|
China
|
Initial
|
27 June 2022
|
27 June 2027
|