View |
|
DRP-13545
|
Omeprazole (as sodium)
|
Omesenz
|
40mg
|
Lyophilized Powder for Injection (IV)
|
-
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
08 March 2023
|
08 March 2028
|
View |
|
HRP-571
|
Povidone Iodine
|
Povigen
|
75 mg/mL (7.5% w/v)
|
Solution
|
-
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
Initial
|
09 March 2023
|
09 March 2028
|
View |
|
HRP-570
|
Povidone-Iodine
|
Raphiodine
|
75 mg/mL (7.5% w/v)
|
Solution
|
-
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
Initial
|
09 March 2023
|
09 March 2028
|
View |
|
DRHR-2215
|
Menthol + Camphor + Methyl Salicylate + Eucalyptus Oil
|
Axe Brand Universal Oil
|
184 mg/46 mg/138 mg/138 mg per mL
|
Medicated Oil
|
-
|
Leung Kai Fook Medical Co Pte Ltd
|
Singapore
|
Initial
|
20 March 2023
|
20 March 2025
|
View |
|
DR-XY48647
|
Erlotinib (as Hydrochloride)
|
Erlox
|
150 mg
|
Film-Coated Tablet
|
-
|
Shandong Confucius Pharmaceutical Co., Ltd.
|
China
|
Initial (Re-application)
|
09 March 2023
|
09 March 2028
|
View |
|
DRP-13599
|
Oral Rehydration Salts
|
Eba-ORS Lychee
|
Each sachet contains:
Sodium Chloride 520 mg
Trisodium Citrate Dihydrate 580 mg
Potassium Chloride 300 mg
Dextrose/Glucose, anhydrous 2.70 g
|
Granules for Solution (Lychee flavor)
|
-
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
Initial (OTC)
|
15 March 2023
|
15 March 2028
|
View |
|
DRP-13598
|
Oral Rehydration Salts
|
Eba-ORS Melon
|
Each sachet contains:
Sodium Chloride 520 mg
Trisodium Citrate Dihydrate 580 mg
Potassium Chloride 300 mg
Dextrose/Glucose, anhydrous 2.70 g
|
Granules for Solution (Melon flavor)
|
-
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
Initial (OTC)
|
15 March 2023
|
15 March 2028
|
View |
|
DRP-13597
|
Oral Rehydration Salts
|
Eba-ORS Strawberry
|
Each sachet contains:
Sodium Chloride 520 mg
Trisodium Citrate Dihydrate 580 mg
Potassium Chloride 300 mg
Dextrose/Glucose, anhydrous 2.70 g
|
Granules for Solution
(Strawberry Flavor)
|
-
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
Initial (OTC)
|
15 March 2023
|
15 March 2028
|
View |
|
DRP-13596
|
Multivitamins
|
Genvit
|
Formulation
Each capsule contains
Ascorbic Acid 400 mg
Niacin (Vitamin B3) 20 mg
Pyridoxine Hydrochloride (Vitamin B6) 15 mg Thiamine Mononitrate (Vitamin B1) 10 mg
dl-Alpha Tocopheryl Acetate (Vitamin E) 10 mg
Riboflavin (Vitamin B2) 5 mg
Retinol Acetate (Vitamin A) 4000 IU
Folic Acid (Vitamin B9) 500 mcg
Cyanocobalamin (Vitamin B12) 30 mcg
Colecalciferol (Vitamin D3) 400 IU
|
Capsule
|
-
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
Initial (OTC)
|
15 March 2023
|
15 March 2028
|
View |
|
DRHR-2214
|
Menthol + Eucalyptus Oil + Camphor
|
Vicks VapoRub Xtra Strong
|
7 g/4.03 g/5.2 g (7%/4.03%/5.2% w/w) per 100 g
|
Ointment
|
-
|
Makson Health Care Pvt. Ltd
|
India
|
Initial (Correction)
|
12 October 2023
|
20 March 2028
|
View |
|
DRP-13601
|
Paracetamol
|
Bmol 125
|
125 mg/5 mL
|
Oral Suspension
|
-
|
Rhydburg Pharmaceuticals Limited.
|
India
|
Initial (OTC)
|
15 March 2023
|
15 March 2028
|
View |
|
DRHR-2217
|
Methyl Salicylate + Camphor + Menthol + Eucalyptus
Oil Mineral Oil
|
Talan Haplacious Oil
|
31.5 g/3 g/3 g/1 g/61.5 g (31.5% w/w/3% w/w/3%
w/w/1% w/w/61.5% w/w) per 100 g
|
Liniment
|
-
|
Talan Haplacious Herbal Manufacturer
|
Philippines
|
Initial
|
21 March 2023
|
21 March 2028
|
View |
|
DRP-13600
|
Paracetamol
|
Bmol 120
|
120mg/5mL
|
Oral Suspension
|
-
|
Rhydburg Pharmaceuticals Limited
|
India
|
Initial (OTC)
|
15 March 2023
|
15 March 2028
|
View |
|
DRP-13594
|
Midazolam (as hydrochloride)
|
Midamicum
|
5 mg/mL
|
Solution for Injection (I.M./I.V./Rectal)
|
-
|
Mefar Ilac Sanayii A.S.
|
Turkey
|
Initial
|
14 March 2023
|
14 March 2028
|
View |
|
DRP-13657
|
Multivitamins + Lysine + Taurine + Zinc
|
Multizee
|
Each 5mL contains:
Retinol (Vitamin A) as Palmitate -2,000 IU
Thiamine Hydrochloride (Vitamin B1) -5 mg
Riboflavin (Vitamin B2) -2 mg
Pyridoxine Hydrochloride (Vitamin B6) -2. mg
Cyanocobalamin (Vitamin B12)-1 mcg
Ascorbic Acid (Vitamin C) -100 mg
Cholecalciferol (Vitamin D3) -400 IU
Nicotinamide (Vitamin B3) -30 mg
Lysine Monohydrochloride -100 mg
Zinc Sulfate (equivalent to 10mg Zinc) -43.86 mg Taurine -50 mg
|
Syrup
|
-
|
Enicar Pharmaceuticals Pvt. Ltd.
|
|
Initial [OTC]
|
29 March 2023
|
29 March 2028
|
View |
|
DRP-13655
|
Paracetamol
|
Whim 120
|
120mg/5mL
|
Oral Suspension
|
-
|
Rhydburg Pharmaceuticals Ltd.
|
|
Initial [OTC]
|
29 March 2023
|
29 March 2028
|
View |
|
DRP-13653
|
Paracetamol
|
R-Nex 120
|
120 mg/5 mL
|
Oral Suspension
|
-
|
Rhydburg Pharmaceuticals Ltd.
|
|
Initial [OTC]
|
24 March 2023
|
24 March 2028
|
View |
|
DRP-13672
|
Ampicillin (as sodium)
|
Corpilyn
|
1 g
|
Powder for Injection (IM/IV)
|
-
|
Uni Medicolabs, Inc.
|
|
Initial
|
24 March 2023
|
24 March 2028
|
View |
|
DRHR-2220
|
Isopropyl Alcohol
|
Alco Lavender
|
70% (v/v)
|
Solution
|
-
|
Greenstone Pharmaceutical, Inc.
|
|
Initial (OTC)
|
23 March 2023
|
23 March 2028
|
View |
|
DRHR-2221
|
Isopropyl Alcohol
|
Alco Lavender
|
70% (v/v)
|
Solution
|
-
|
Greenstone Pharmaceutical, Inc.
|
|
Initial (OTC)
|
23 March 2023
|
23 March 2028
|