| View |
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DR-XY49110
|
Telmisartan
|
Telarb
|
80 mg
|
Tablet
|
Angiotensin II Receptor Blocker (ARB)
|
Inventia Healthcare Limited
|
India
|
Initial
|
18 June 2024
|
18 June 2029
|
| View |
|
DRP-15318
|
Telmisartan + Hydrochlorothiazide
|
Diucard
|
40 mg/ 12.5 mg
|
Tablet
|
Angiotensin II Receptor Blocker (ARB) and Diuretic
|
Ravian Life Science Pvt. Ltd.
|
India
|
Initial
|
18 June 2024
|
18 June 2029
|
| View |
|
DRP-15312
|
Mupirocin
|
Bactriplex
|
20 mg/g (2% w/w)
|
Ointment
|
Antibacterial
|
SM Pharmaceuticals Sdn. Bhd.
|
Malaysia
|
Initial
|
18 June 2024
|
18 June 2029
|
| View |
|
DR-XY49107
|
Piperacillin (as sodium) + Tazobactam (as sodium)
|
Aezitam 4.5
|
4 g/ 500 mg
|
Powder for Injection (I.M./I.V.)
|
Antibacterial (Penicillin/ Beta-Lactamase Inhibitor)
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
18 June 2024
|
18 June 2029
|
| View |
|
DR-XY49108
|
Piperacillin (as sodium) + Tazobactam (as sodium)
|
Aezitam 2.25
|
2 g/250 mg
|
Powder for Injection (I.M./I.V.)
|
Antibacterial (Penicillin/ Beta-Lactamase Inhibitor)
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
18 June 2024
|
18 June 2029
|
| View |
|
DRP-15322
|
Pantoprazole (as sodium)
|
Pentariv 40.
|
40 mg
|
Lyophilized Powder for Injection (IV)
|
Proton Pump Inhibitor
|
East African (India) Overseas
|
India
|
Initial
|
18 June 2024
|
18 June 2029
|
| View |
|
DRP-15311
|
Tranexamic Acid
|
Hemomeds
|
500 mg/5 mL (100 mg/mL)
|
Solution for Injection
(IM/IV)
|
Anti-fibrinolytic
|
Furen Pharmaceutical Group Co., Ltd.
|
China
|
Initial
|
18 June 2024
|
18 June 2029
|
| View |
|
DRP-15310
|
Tranexamic Acid.
|
Furenex
|
500 mg/5 mL (100 mg/mL)
|
Solution for Injection
(IM/IV)
|
Anti-fibrinolytic
|
Furen Pharmaceutical Group Co., Ltd.
|
China
|
Initial
|
18 June 2024
|
18 June 2029
|
| View |
|
DR-XY49111
|
Piperacillin (as sodium) + Tazobactam (as sodium)
|
Tazin
|
2 g/250 mg
|
Powder for Injection (I.M./I.V.)
|
Antibacterial (Penicillin/ Beta-Lactamase Inhibitor)
|
United Biotech Pvt. Ltd.
|
India
|
Initial
|
18 June 2024
|
18 June 2029
|
| View |
|
DRHR-2367
|
Menthol Eucalyptus Oil + Camphor
|
Vaporin Aromatheraphy Oil-Supreme
|
50.160 g/ 6.160g/ 2.640 g per 100 mL
|
Liniment
|
Counterirritant
|
International Pharmaceuticals, Inc.
|
Philippines
|
Initial
|
14 June 2024
|
14 June 2026
|
| View |
|
DRP-15320
|
Carvedilol
|
Medcarv 6.25
|
6.25 mg
|
Film Coated Tablet
|
Alpha and Beta Blocking Agent
|
Exemed Pharmaceuticals
|
India
|
Initial
|
18 June 2024
|
18 June 2029
|
| View |
|
DRP-15321
|
Carvedilol
|
Medcarv 12.5
|
12.5mg
|
Film-Coated Tablet
|
Alpha and Beta Blocking Agent
|
Exemed Pharmaceuticals
|
India
|
Initial
|
18 June 2024
|
18 June 2029
|
| View |
|
DRP-15319
|
Montelukast (as sodium)
|
Apilone
|
4 mg
|
Chewable Tablet
|
Leukotriene Receptor Antagonist
|
Pharmathen SA
|
Greece
|
Initial (Correction)
|
22 August 2024
|
18 June 2029
|
| View |
|
DRP-15221
|
Tranexamic Acid
|
Accetran
|
500 mg/5 mL (100 mg/mL)
|
Solution for Injection (IV)
|
Antifibrinolytic
|
Maxitech Pharma (Pvt) Ltd.
|
Pakistan
|
Initial (Re-Application)
|
18 June 2024
|
18 June 2029
|
| View |
|
DRP-14426
|
Cefixime (as trihydrate)
|
Cefthix
|
400 mg
|
Capsule
|
Antibacterial (Third-generation Cephalosporin)
|
Medico Remedies Limited
|
India
|
Initial (Correction)
|
18 June 2024
|
04 September 2028
|
| View |
|
DRP-15331
|
Esomeprazole (as sodium)
|
Exzomel
|
40 mg
|
Lyophilized Powder for Injection (IV)
|
Proton Pump Inhibitor
|
Lyka Labs Limited
|
India
|
Initial
|
20 June 2024
|
20 June 2029
|
| View |
|
DRP-15332
|
Telmisartan + Hydrochlorothiazide
|
Pretension Plus
|
80 mg/12.5 mg
|
Tablet
|
Angiotensin II Receptor Blocker (ARB) + Diuretic.
|
Dasan Pharmaceutical Co., Ltd.
|
Korea
|
Initial
|
20 June 2024
|
20 June 2029
|
| View |
|
DRP-15333
|
Telmisartan+Hydrochlorothiazide
|
Pretension Plus
|
40 mg + 12.5 mg
|
Tablet
|
Antihypertensive
|
Dasan Pharmaceutical Co., Ltd.
|
Korea
|
Initial
|
20 June 2024
|
20 June 2029
|
| View |
|
DRP-15325
|
Mesalazine
|
Zelan
|
1 g
|
Rectal Suppository
|
Intestinal Antiinflammatory Agent
|
Farmaprim Ltd.
|
Maldova
|
Initial
|
19 June 2024
|
19 June 2029
|
| View |
|
DRP-15327
|
Adenosine
|
Carnosin
|
6 mg/2ml
|
Solution for Injection (IV)
|
Antiarrythmic
|
Samarth Life Sciences Pvt. Ltd. (Unit II)
|
India
|
Initial
|
20 June 2024
|
20 June 2029
|