| View |
|
DRP-12684
|
Aciclovir
|
Novclovir
|
50 mg/g (5% w/w)
|
Topical Cream
|
-
|
S Kant Healthcare Ltd.
|
India
|
Initial
|
23 September 2022
|
23 September 2027
|
| View |
BR-1420_PI_01.pdf
|
BR-1420
|
Insulin Degludec + Liraglutide
|
Xultophy
|
100 U/3.6mg per mL
|
Solution For Injection (SC)
|
Antidiabetics
|
Novo Nordisk Pharmaceutical Industries, LP
|
United States of America
|
Initial
|
20 September 2022
|
20 September 2027
|
| View |
|
DRP-12633
|
Cetirizine Hydrochloride + Phenylephrine Hydrochloride
|
Phencet
|
5 mg / 10 mg
|
Film Coated Tablet
|
Antihistamine/ Nasal Decongestant
|
Phil. United Pharma Corp.
|
Philippines
|
Initial
|
20 September 2022
|
20 September 2027
|
| View |
|
DRP-12661
|
Loratadine
|
Lorago 5 CT
|
5 mg
|
Chewable Tablet
|
Antihistamine
|
Phil. United Pharma Corp.
|
Philippines
|
Initial (OTC) (Correction)
|
13 October 2022
|
20 September 2027
|
| View |
|
DRP-12731
|
Iohexol
|
Novahexol
|
647 mg/ mL (eq. to 300 mg Iodine/ mL)
|
Solution for Intravenous (I.V.)/ Intrathecal Injection
|
Non-Ionic Radiocontrast Media
|
Aroma İlaç San. Ltd. Şti
|
Turkey
|
Initial
|
29 September 2022
|
29 September 2027
|
| View |
|
DRP-12740
|
Irbesartan
|
Irbefar
|
150 mg
|
Film-Coated Tablet
|
-
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial (Correction)
|
26 October 2022
|
29 September 2027
|
| View |
|
DRP-12670
|
Esomeprazole(As Sodium)
|
Novaprazole
|
40 mg
|
Lyophilized Powder for Injection/I.V. Infusion
|
Proton Pump Inhibitor
|
Steril-Gene Life Sciences (P) Ltd.
|
India
|
Initial
|
21 September 2022
|
21 September 2027
|
| View |
|
DR-XY48367
|
Metformin hydrochloride + Sitagliptin (as phosphate)
|
Torsit M 1000
|
1 g/50 mg
|
Film-Coated Tablet
|
Blood glucose lowering drug
|
Torrent Pharmaceuticals Ltd.
|
India
|
Initial
|
22 September 2022
|
22 September 2027
|
| View |
|
DRP-12678
|
Sevelamer carbonate
|
Khrizvela
|
800 mg
|
Film-Coated Tablet
|
Phosphate Binder
|
Samson Laboratories Pvt. Ltd.
|
India
|
Initial (Reconstruction)
|
04 June 2024
|
22 September 2027
|
| View |
|
DRP-12626
|
Divalproex sodium (equivalent to Valproic acid)
|
Lepsodex ER
|
250 mg
|
Extended Release Tablet
|
Antiepileptic (Fatty Acid Derivative)
|
PT Dexa Medica
|
Indonesia
|
Initial
|
16 September 2022
|
16 September 2027
|
| View |
|
DR-XY48375
|
Mannitol
|
None
|
100g/500mL
|
Solution for IV Infusion
|
Irrigating Solution
|
Shijiazhuang No. 4 Pharmaceutical Co., Ltd.
|
China
|
Initial
|
23 September 2022
|
23 September 2027
|
| View |
|
DRHR-2154
|
Ethyl Alcohol
|
IRIESH
|
70mL per 100mL (70% v/v)
|
Topical Solution
|
Antiseptic/Disinfectant
|
Zelwalk Enterprises
|
Philippines
|
Initial (HR)
|
23 September 2022
|
23 September 2027
|
| View |
|
DRP-12694
|
Bisoprolol Fumarate
|
None
|
10 mg
|
Film-Coated Tablet
|
Beta Blocking Agent
|
United International Pharma Co. Ltd.
|
Vietnam
|
Initial
|
23 September 2022
|
23 September 2027
|
| View |
|
DR-XY48353
|
Bisoprolol fumarate
|
Bisodac 10
|
10 mg
|
Film-Coated Tablet
|
Beta Blocking Agent
|
Aurobindo Pharma Limited
|
India
|
Initial
|
16 September 2022
|
16 September 2027
|
| View |
|
DRP-12703
|
Telmisartan
|
Merit
|
80 mg
|
Tablet
|
-
|
Krka, d. d., Novo mesto
|
Slovenia
|
Initial
|
27 September 2022
|
27 September 2027
|
| View |
|
DRP-12654
|
Valproic Acid (as Sodium Valproate)
|
Valpros Pedia
|
250 mg / 5 mL
|
Syrup (Cherry Flavor)
|
Antiepileptic (Fatty acid derivative)
|
PT. Darya-Varia Laboratoria TBK
|
Indonesia
|
Initial
|
20 September 2022
|
20 September 2027
|
| View |
|
DR-XY48370
|
Telmisartan + Hydrochlorothiazide
|
Telmi HCT
|
40mg/12.5mg
|
Tablet
|
Angiotensin II receptor blocker (ARB) and diuretic
|
Ajanta Pharma Limited
|
India
|
Initial
|
22 September 2022
|
22 September 2027
|
| View |
|
DRP-12710
|
Prednisolone (As Sodium Phosphate )
|
Drenisole
|
15 mg/5 mL
|
Syrup (Vanilla-Strawberry Flavor)
|
-
|
Lifesquare Laboratories Inc.
|
Philippines
|
Initial
|
28 September 2022
|
28 September 2027
|
| View |
|
DR-XY48361
|
Pregabalin
|
Prelica
|
75 mg
|
Capsule
|
Antiepileptic
|
Duopharma (M) Sdn. Bhd.
|
Malaysia
|
Initial (Correction)
|
09 November 2022
|
19 September 2027
|
| View |
|
DR-XY48360
|
Pregabalin
|
Prelica
|
150 mg
|
Capsule
|
Antiepileptic
|
Duopharma (M) Sdn. Bhd.
|
Malaysia
|
Initial (Correction)
|
09 November 2022
|
19 September 2027
|