| View |
|
DR-XY48479
|
Leuprorelin Acetate
|
Luprolex
|
1.88mg/mL
|
Powder For Prolong-Release Suspension for Injection (IM/SC)
|
-
|
Takeda Pharmaceutical Company Limited (Hikari
Plant)
|
Japan
|
Initial
|
24 November 2022
|
24 November 2027
|
| View |
|
DR-XY48478
|
Leuprorelin Acetate
|
Luprolex
|
3.75mg/mL
|
Powder For Prolong-Release Suspension for Injection (IM/SC)
|
-
|
Takeda Pharmaceutical Company Limited (Hikari
Plant)
|
Netherlands
|
Initial
|
24 November 2022
|
24 November 2027
|
| View |
|
DRP-13044
|
Paracetamol + Thiamine (Vitamin B1) + Pyridoxine (Vitamin B6) + Cyanocobalamin (Vitamin B12)
|
None
|
500 mg/ 50 mg/ 100 mg/ 100 mcg
|
Film Coated Tablet
|
-
|
Azarias Pharmaceutical Laboratories Inc,
|
Philippines
|
Initial
|
22 November 2022
|
22 November 2027
|
| View |
|
DR-XY48481
|
Piroxicam + Methyl Salicylate + Methol + Eugenol
|
FlanaxPlus
|
5 mg/ 102 mg/ 54.3 mg/ 13.7 mg per gram
|
Topical Gel
|
-
|
PT Taisho Pharmaceutical Indonesia Tbk.
|
Indonesia
|
Initial [OTC](Correction)
|
17 January 2023
|
22 November 2027
|
| View |
|
DR-XY48477
|
Leuprorelin Acetate
|
Luprolex
|
11.25mg/mL
|
Powder for Prolonged-Release
Suspension for Injection (IM/SC)
|
-
|
Takeda Pharmaceutical Company Limited (Hikari
Plant)
|
United Kingdom
|
Initial
|
24 November 2022
|
24 November 2027
|
| View |
|
DRP-13071
|
Pyrazinamide
|
Saphyrazin-500
|
500 mg/ 5 mL
|
Oral Suspension
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
25 November 2022
|
25 November 2027
|
| View |
|
DR-XY48504
|
Tretinoin + Hydroquinone
|
Maxi-Peel Solution No. 4
|
25 mg (0.025% w/w)/4 g (4% w/w) per 100 g
|
Topical Solution
|
-
|
Splash Corporation
|
Philippines
|
Initial (OTC)
|
25 November 2022
|
25 November 2027
|
| View |
DRP-13084_PI_01.pdf
|
DRP-13084
|
Febuxostat
|
Feblorika 80
|
80mg
|
Film-Coated Tablet
|
-
|
Mankind Pharma Limited (Unit II)
|
Thailand
|
Initial
|
25 November 2022
|
25 November 2027
|
| View |
|
DRP-12926
|
Montelukast (As Sodium) + Levocetirizine Hydrochloride
|
Cetikast
|
10 mg/5 mg
|
Film-Coated Tablet
|
-
|
Theon Pharmaceuticals Limited
|
India
|
Initial
|
02 November 2022
|
02 November 2027
|
| View |
|
DR-XY48484
|
Abiraterone Acetate
|
Abiravitae
|
250mg
|
Tablet
|
-
|
Atlas Pharm, S.A.
|
Nepal
|
Initial
|
21 November 2022
|
21 November 2027
|
| View |
|
DR-XY48491
|
Acetylcysteine + Zinc
|
Exflem Plus
|
600 mg / 5 mg
|
Film-Coated Tablet
|
-
|
Amherst Laboratories, Inc.
|
Philippines
|
Monitored Release (MR)
|
25 November 2022
|
25 November 2027
|
| View |
|
DRP-5095-03
|
Losartan Potassium
|
None
|
50 mg
|
Film-Coated Tablet
|
-
|
Pascual Laboratories, Inc.
|
Philippines
|
Initial
|
16 June 2021
|
07 December 2025
|
| View |
|
DRP-4044-02
|
Salbutamol (as sulfate)
|
None
|
100 mcg per Actuation Metered Dose Inhaler
|
|
Selective Beta-2-Adrenoreceptor Agonist
|
Midas Care Pharmaceutical Pvt. Ltd.
|
India
|
Renewal
|
06 December 2022
|
19 December 2027
|
| View |
|
DRP-4089-01
|
Ondansetron (as hydrochloride)
|
Z-Tron
|
2 mg/mL (4 mg/2 mL)
|
Solution for Injection (IM/IV)
|
Serotonin (5HT3) Antagonist
|
Scott-Edil Pharmacia Ltd.
|
India
|
Automatic Renewal
|
06 December 2022
|
08 November 2027
|
| View |
|
DRP-4961-20
|
Cefixime (as trihydrate)
|
Acecef
|
100 mg/5 mL
|
Powder for Suspension
|
Antibacterial (Cephalosporin)
|
Sakar Healthcare Pvt. Ltd
|
India
|
Renewal
|
14 January 2023
|
27 November 2028
|
| View |
|
DRP-5271-05
|
Carboplatin
|
Carboget
|
10 mg/ mL (450 mg/ 45 mL)
|
Solution for IV Infusion
|
Antineoplastic
|
Getwell Pharmaceuticals
|
India
|
Renewal
|
27 February 2024
|
16 April 2029
|
| View |
|
DRP-5682-03
|
Cefoxitin (as sodium)
|
Foxi
|
1 g
|
Powder for Injection (I.M/I.V.)
|
Antibacterial
|
Phil Inter Pharma Co., Ltd.
|
Vietnam
|
Renewal
|
28 September 2024
|
05 November 2029
|
| View |
|
DRP-5974-05
|
Levofloxacin (as hemihydrate)
|
CELEVO
|
750 mg
|
Film-Coated Tablet
|
-
|
Scott-Edil Pharmacia Limited
|
India
|
CLIDP Conversion
|
07 December 2022
|
11 February 2025
|
| View |
|
DRP-6713-05
|
Fenofibrate
|
Fenibra
|
160 mg
|
Film-Coated Tablet
|
-
|
Ravian Life Science Pvt. Ltd.
|
India
|
CLIDP Conversion
|
07 December 2022
|
06 June 2026
|
| View |
|
DRP-8728-01
|
Paracetamol
|
Aemol
|
150 mg/ mL
|
Solution for Infusion (IM/IV)
|
Analgesic/ Antipyretic
|
CSPC Ouyi Pharmaceutical Co. Ltd.
|
China
|
Renewal
|
02 August 2024
|
30 July 2029
|