| View |
|
DRHR-2202
|
Isopropyl Alcohol
|
Pro-Defense
|
70% (v/v)
|
Solution with moisturizer
|
-
|
Medipak Manufacturing Inc.
|
Philippines
|
Initial
|
14 February 2023
|
14 February 2025
|
| View |
|
DRHR-2206
|
Ethyl Alcohol
|
Uni Alco Safe
|
70% (v/v)
|
Solution with moisturizer
|
-
|
Uni Elements Enterprises
|
Philippines
|
Initial
|
14 February 2023
|
14 February 2028
|
| View |
|
DR-XY48630
|
Multivitamins + Minerals + Chlorella pyrenoidosa +
Panax ginseng L. (Korean Ginseng) Root + Lecithin +
Rutin + Taurine
|
Restor-F
|
Each softgel capsule contains: Retinyl Palmitate (Vitamin A)-2700 IU Cholecalciferol (Vitamin D3)-200 IU Ascorbic Acid (Vitamin C)-60 mg Niacinamide (Vitamin B3)-30 mg dl-Alpha Tocopheryl Acetate (Vitamin E)-10 mg Pyridoxine (Vitamin B6)-3 mg Thiamine (Vitamin B1)-1.8 mg Riboflavin (Vitamin B2)-1.8 mg Folic Acid (Vitamin B9)-250 mcg Cyanocobalamin (Vitamin B12) -3mcg
Calcium (Equivalent to 50mg Calcium Carbonate)-20 mg Iron (Equivalent to 30.77mg Ferrous Fumarate)-10 mg Zinc (Equivalent to 27.45mg Zinc Sulfate Monohydrate) -10 mg
Chlorella pyrenoidosa-150 mg
| Panax ginseng L. (Korean Ginseng) Root-50 mg Lecithin - 70 mg Rutin- 50 mg Taurine-200 mg
|
Softgel Capsule
|
-
|
Northfield Laboratories Inc.
|
Philippines
|
Initial (OTC)
|
17 February 2023
|
29 January 2026
|
| View |
|
BR-1440
|
Bacterial Lysate
|
Broncho-Vaxom
|
7 mg
|
Capsule
|
Other Respiratory System Products
|
OM Pharma S.A. Meyrin
|
Switzerland
|
Automatic Renewal
|
14 April 2023
|
05 June 2028
|
| View |
|
DR-XY48614
|
Rimegepant (as sulfate)
|
Nurtec
|
75 mg
|
Orally Disintegrating Tablet
|
-
|
Catalent UK Swindon Zydis Limited
|
United Kingdom
|
Monitored Release
|
10 February 2023
|
10 February 2028
|
| View |
|
DRP-13393
|
Gliclazide + Metformin Hydrochloride
|
Saphzimet
|
80 mg/ 500 mg
|
Film-Coated Tablet
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial (Re-application)
|
10 February 2023
|
10 February 2028
|
| View |
|
DRP-13377
|
Losartan Potassium + Hydrochlorothiazide
|
Losangio-HT
|
100 mg / 25 mg
|
Film-Coated Tablet
|
-
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial
|
08 February 2023
|
08 February 2028
|
| View |
|
DRP-13386
|
Mecobalamin
|
None
|
500 mcg/mL
|
Solution for Injection (IM/IV)
|
-
|
Ta Fong Pharmaceutical Co., Ltd.
|
Taiwan
|
Initial
|
09 February 2023
|
09 February 2028
|
| View |
|
DR-XY48611
|
Fondaparinux Sodium
|
Fondux
|
2.5 mg/0.5 mL
|
Solution For Injection (IV/SC)
|
Antithrombotic Agent
|
PT Ferron Par Pharmaceuticals
|
Indonesia
|
Initial
|
10 February 2023
|
10 February 2028
|
| View |
|
DRP-13387
|
Citicoline (as sodium)
|
Brainolin
|
125mg/mL
|
Solution For Injection (IM/IV)
|
-
|
PT Ferron Par Pharmaceuticals
|
Indonesia
|
Initial
|
09 February 2023
|
09 February 2028
|
| View |
|
DRP-13376
|
Telmisartan + Amlodipine (As Besilate)
|
Telmisaph-A90
|
80mg/10mg
|
Tablet
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
08 February 2023
|
08 February 2028
|
| View |
|
DRP-13370
|
Rosuvastatin (as calcium)
|
None
|
40 mg
|
Film-Coated Tablet
|
-
|
Centurion Laboratories Pvt. Ltd.
|
India
|
Initial
|
08 February 2023
|
08 February 2028
|
| View |
|
DRP-13379
|
PREGABALIN + METHYLCOBALAMIN
|
LYRIMET
|
75mg/750mcg
|
Capsule
|
Antiepileptic/ Vitamin (Cyanocobalamin analogue)
|
Bafna Pharmaceuticals Limited
|
India
|
Renewal
|
25 August 2024
|
08 February 2030
|
| View |
DR-XY48585_PI_01.pdf
|
DR-XY48585
|
Lurasidone Hydrochloride
|
Latuda
|
40 mg
|
Film Coated Tablet
|
-
|
Bushu Pharmaceuticals Ltd. (Kawagoe Factory)
|
Japan
|
Monitored Release
|
08 February 2023
|
08 February 2028
|
| View |
|
DRP-13394
|
Rosuvastatin (as calcium)
|
None
|
20mg
|
Film-Coated Tablet
|
-
|
Centurion Laboratories Pvt. Ltd.
|
India
|
Initial
|
10 February 2023
|
10 February 2028
|
| View |
|
DRP-13295
|
Amikacin (as sulfate)
|
Ambikacin-250
|
125 mg/mL (250 mg/2 mL)
|
Solution for Injection (IM/IV)
|
-
|
Cooper Pharma Limited
|
India
|
Initial
|
08 February 2023
|
08 February 2028
|
| View |
|
DRP-13296
|
Amikacin (as sulfate)
|
Ambikacin-100
|
50 mg/mL (100 mg/2 mL)
|
Solution for Injection
(IM/IV)
|
-
|
Cooper Pharma Limited
|
India
|
Initial
|
08 February 2023
|
08 February 2028
|
| View |
DR-XY48613_PI_01.pdf
|
DR-XY48613
|
Empagliflozin + Linagliptin
|
Glyxambi
|
10 mg/5 mg
|
Film-Coated Tablet
|
-
|
Rottendorf Pharma GmbH
|
Germany
|
Initial
|
10 February 2023
|
10 February 2028
|
| View |
DR-XY48612_PI_01.pdf
|
DR-XY48612
|
Empagliflozin + Linagliptin
|
Glyxambi
|
25 mg/5 mg
|
Film-Coated Tablet
|
-
|
Rottendorf Pharma GmbH
|
Germany
|
Initial
|
10 February 2023
|
10 February 2028
|
| View |
|
DRP-13369
|
Tacrolimus
|
Tacrohab
|
1 mg/g (0.1%)
|
Ointment
|
-
|
Genuone Sciences Inc.
|
Korea
|
Initial
|
08 February 2023
|
08 February 2028
|