| View |
|
DRP-15866
|
Ticagrelor
|
Ticafred
|
90 mg
|
Film-Coated Tablet
|
Platelet Aggregation Inhibitor Excl. Heparin
|
Fredun Pharmaceuticals Limited
|
India
|
Initial
|
25 September 2024
|
25 September 2029
|
| View |
|
DRHR-2382
|
Ethyl Alcohol
|
Angel's Flo
|
70 ml per 100 ml (70% v/v)
|
Topical Solution
|
Antiseptic/Disinfectant
|
C and H Cosmetics Industry
|
Philippines
|
Initial
|
20 September 2024
|
20 September 2029
|
| View |
|
DRP-15874
|
Tranexamic Acid
|
None
|
100 mg/mL (500 mg/mL)
|
Solution for Injection (IV)
|
Antifibrinolytic (Amino Acid)
|
Skymap Healthcare Pvt. Ltd.
|
India
|
Initial
|
25 September 2024
|
25 September 2029
|
| View |
|
DR-XY49219
|
Montelukast
(as
dihydrochloride as sodium)
|
Monagio-L
|
10 mg/5 mg
|
Film-Coated Tablet
|
Leukotriene Receptor Antagonist/ Antihistamine (Piperazine derivative)
|
Agio Pharmaceuticals Ltd.
|
India
|
Initial
|
20 September 2024
|
20 September 2029
|
| View |
|
DRP-15849
|
Rosuvastatin (as Calcium)
|
Rosuvin 10
|
10 mg
|
Film-Coated Tablet
|
HMG CoA Reductase Inhibitor
|
PSA Chemicals & Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
23 September 2024
|
23 September 2029
|
| View |
|
DRP-15781
|
Esomeprazole (as sodium)
|
Esosky-40
|
40 mg
|
Powder for Solution for Injection (IV)
|
Proton Pump Inhibitor
|
Skymap Healthcare Pvt. Ltd.
|
India
|
Initial
|
25 September 2024
|
25 September 2029
|
| View |
|
DRP-15782
|
Esomeprazole (as sodium)
|
Esosky-40
|
40 mg
|
Powder for Solution for Injection
|
Proton Pump Inhibitor
|
Skymap Healthcare Pvt. Ltd.
|
India
|
Initial
|
24 September 2024
|
24 September 2029
|
| View |
|
DRP-15847
|
Sodium Chloride
|
Nasofast
|
6.50 mg (0.65% w/v) per mL
|
Nasal Solution (Spray)
|
Solution for Irrigation.
|
Meridian Enterprises Pvt. Ltd.
|
India
|
Initial [OTC]
|
23 September 2024
|
23 September 2029
|
| View |
|
DRHR-2381
|
Ethyl Alcohol
|
Full Defenz
|
70 ml per 100 ml (70% v/v)
|
Topical Solution
|
Antiseptic/Disinfectant
|
Am-Europharma Corporation
|
Philippines
|
Initial
|
20 September 2024
|
20 September 2029
|
| View |
|
DRHR-2383
|
Ethyl Alcohol
|
Dynast
|
70 ml per 100 ml (70% v/v)
|
Topical Solution
|
Antiseptic/Disinfectant
|
Dynast Cosmetics & Household Manufacturing Inc
|
Philippines
|
Initial
|
23 September 2024
|
23 September 2029
|
| View |
|
DR-XY49217
|
Telmisartan + Hydrochlorothiazide
|
Telatraz Plus
|
80 mg/12.5 mg
|
Tablet
|
Angiotensin II Receptor Blocker (ARB)/Diuretic)
|
Alembic Pharmaceuticals Limited
|
India
|
Initial
|
20 September 2024
|
20 September 2029
|
| View |
|
DR-XY49216
|
Telmisartan + Hydrochlorothiazide
|
Telatraz Plus
|
80 mg/25 mg
|
Tablet
|
Angiotensin II Receptor Blocker (ARB)/Diuretic)
|
Alembic Pharmaceuticals Limited
|
India
|
Initial
|
20 September 2024
|
20 September 2029
|
| View |
|
DR-XY49218
|
Telmisartan + Hydrochlorothiazide
|
Telatraz Plus
|
40 mg/12.5 mg
|
Tablet
|
Angiotensin II Receptor Blocker (ARB)/Diuretic)
|
Alembic Pharmaceuticals Limited
|
India
|
Initial
|
20 September 2024
|
20 September 2029
|
| View |
|
DR-XY49231
|
Moxifloxacin (as hydrochloride)
|
Svoz
|
5 mg/mL (0.5% w/v)
|
Ophthalmic Solution
|
Fluoroquinolone
|
Siam Bheasach Co., Ltd.
|
Thailand
|
Initial
|
25 September 2024
|
25 September 2029
|
| View |
|
DRP-15839
|
Telmisartan
|
Beisartan
|
80 mg
|
Tablet
|
Angiotensin II Receptor Blocker (ARB)
|
Hebei Tiancheng Pharmaceutical Co., Ltd.
|
China
|
Initial
|
20 September 2024
|
20 September 2029
|
| View |
|
DRP-15832
|
Levodopa + Carbidopa (as monohydrate) + Entacapone
|
Lecarpone
|
100 mg/25 mg/200 mg
|
Film Coated Tablet
|
Anti-Parkinson Drug (Dopaminergic Agent)
|
Baroque Pharmaceuticals Pvt. Ltd
|
India
|
Initial
|
24 September 2024
|
24 September 2029
|
| View |
|
DRP-15833
|
Levodopa + Carbidopa (as monohydrate) + Entacapone
|
Lecarpone
|
150 mg/37.5 mg/200 mg
|
Film Coated Tablet
|
Anti-Parkinson Drug (Dopaminergic Agent)
|
Baroque Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
24 September 2024
|
24 September 2029
|
| View |
|
DRP-8708-05
|
Esomeprazole
|
Esocass
|
40 mg
|
Enteric-Coated Tablet
|
Proton Pump Inhibitor
|
Gracure Pharmaceutical Ltd
|
India
|
CLIDP Conversion
|
07 March 2023
|
07 February 2025
|
| View |
|
DRP-11209-02
|
Ampicillin (as sodium) + Sulbactam (as sodium)
|
Ampisulmax
|
1g / 500mg
|
Powder for Injection (I.V. / I.M.)
|
Antibacterial (Penicillin-Beta-Lactamase Inhibitor Combination)
|
Reyoung Pharmaceutical Co., Ltd
|
China
|
CLIDP Conversion
|
22 March 2023
|
15 February 2027
|
| View |
|
DRP-11209-03
|
Ampicillin (as sodium) + Sulbactam (as sodium)
|
Ansulmax
|
1g/500mg
|
Powder for Injection (IV/IM)
|
Antibacterial (Penicillin-Beta-Lactamase Inhibitor Combination)
|
Reyoung Pharmaceutical Co., Ltd
|
China
|
CLIDP Conversion
|
22 March 2023
|
15 February 2027
|