| View |
|
DRP-11678
|
Carbimazole
|
Neomerdin
|
5 mg
|
Tablet
|
Antithyroid Agent
|
Sydenham Laboratories, Inc.
|
Philippines
|
Renewal
|
16 April 2024
|
27 July 2029
|
| View |
|
BR-1400
|
Trastuzumab
|
Trazimera
|
440 mg
|
Powder for Concentrate for Solution for Infusion (IV)
|
Monoclonal Antibodies
|
Pfizer Manufacturing Belgium NV
|
Belgium
|
Initial
|
21 April 2022
|
21 April 2027
|
| View |
|
DRHR-2136
|
Sulfur
|
Dr. S. Wong's Sulfur Soap
|
2 g per 100 g
|
Soap
|
Antiparasitic/Antifungal
|
International Pharmaceuticals, Inc.
|
Philippines
|
Initial
|
20 April 2022
|
20 April 2027
|
| View |
|
DRHR-2135
|
Aceite de Alcamforado
|
None
|
100mg per mL
|
Solution
|
Counterirritant
|
International Pharmaceuticals, Inc.
|
Philippines
|
Automatic Renewal (E-AR)
|
29 December 2023
|
20 April 2029
|
| View |
|
DRP-11672
|
Rabeprazole Sodium
|
Azlo
|
20mg
|
Enteric Coated Tablet
|
-
|
Lincoln Pharmaceuticals Ltd.
|
India
|
-
|
11 April 2022
|
11 April 2027
|
| View |
|
DRP-6717-16
|
Omeprazole (as sodium)
|
Omestop II
|
40 mg
|
Lyophilized Powder for IV Injection
|
Proton Pump Inhibitor
|
Alwin DMD Pharmaceuticals
|
India
|
Initial
|
18 April 2022
|
02 June 2026
|
| View |
|
DR-XY47948
|
D-Alpha Tocopherol
(Vitamin E)
|
Fern-E
|
400 I.U.
|
Softgel Capsule
|
Vitamin
|
Hizon Laboratories, Inc.
|
Philippines
|
Initial
|
20 April 2022
|
20 April 2027
|
| View |
|
DRP-11710
|
Colecalciferol (Vitamin D3)
|
Zunvit 1000
|
1000 IU
|
Tablet
|
Vitamin
|
Life Square Laboratories, Inc.
|
Philippines
|
Initial
|
20 April 2022
|
20 April 2027
|
| View |
|
DRP-11709
|
Colecalciferol (Vitamin D3)
|
Zunvit
|
5000 IU
|
Tablet
|
Vitamin
|
Life Square Laboratories, Inc.
|
Philippines
|
Initial
|
20 April 2022
|
20 April 2027
|
| View |
|
DRHR-2134
|
Povidone Iodine
|
Oradine
|
4.5 mg/mL (0.45% w/v)
|
Throat Spray Solution
|
Antiseptic
|
Kohl Industries Corporation
|
philippines
|
Initial
|
19 April 2022
|
19 April 2027
|
| View |
|
DRP-11706
|
Paracetamol
|
None
|
100 mg/mL
|
Suspension (Oral Drops)
|
Analgesic / Antipyretic
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial (OTC)
|
19 April 2022
|
19 April 2027
|
| View |
|
DR-XY47928
|
Peritoneal Dialysis Solution with 4.25% Dextrose
|
CAPD/DPCA 3 Stay Safe Link Solution for Peritoneal Dialysis
|
Each 1000mL contains:
Sodium Lactate Sodium Chloride Magnesium Chloride Hexahydrate
Calcium Chloride Dihydrate Glucose Monohydrate (Glucose anhydrous)
3.925g 5.786g 0.1017g 0.2573g 42.5g
|
Peritoneal Dialysis Solution
|
Peritoneal Dialysis Solution
|
Fresenius Medical Care Production SDN. BHD.
|
Malaysia
|
Initial (Rx)(Correction)
|
07 August 2022
|
18 April 2027
|
| View |
|
DR-XY47925
|
Pacliatcel
|
None
|
6mg/mL (100mg / 16.7mL)
|
Solution for IV Infusion
|
Antineoplastic
|
Venus Remedies, Limited
|
India
|
Initial
|
13 April 2022
|
13 April 2027
|
| View |
|
DR-XY47954
|
Peritoneal Dialysis Solution with 1.5% Dextrose
|
CAPD/DPCA 2 Stay Safe Link
|
Formulation: Each L of Solution contains: Glucose anhydrous-15 g (equivalent to 16.5 g glucose monohydrate) Calcium Chloride Dihydrate-257.3 mg
Magnesium Chloride Hexahydrate-101.7 mg Sodium Lactate-3.925 g Sodium Chloride-5.786 g
Ca**-1.75
Na**-134
CI-0.5 (S) - Lactate-35 Glucose -83.2
|
Dialysis Solution
(Intraperitoneal)
|
Peritoneal Dialytics
|
Fresenius Medical Care Production Sdn. Bhd.
|
Malaysia
|
Initial
|
21 April 2022
|
21 April 2027
|
| View |
|
DRP-11702
|
Multivitamins + Minerals
|
Saphvimin
|
100 mg
50 IU
50 mg 15 mg
15 mg 10 mg
10 mg 5 mg 3.2 my
3.2 mg 4000 IU
Formulation: Each Film-Coated Tablet contains: Ascorbic Acid dl-Alpha-Tocopheryl Acetate (Vitamin E) (equivalent to 22.5 mg dl-Alpha-Tocopheryl Acetate) Nicotinamide (Vitamin B3) Pantotheni cid (Vitamin B5) Riboflavin (Vitamin B2) Retinyl Palmitate (Vitamin A) (equivalent to 2.2 mg Retinyl Palmitate) Thiamine Mononitrate (Vitamin 31) Folic Acid (Vitamin B9) Biotin (Vitamin B7) Vitamin Ki Cyanocobalamin (Vitamin B12) Cholecalciferol (Vitamin D3) (equivalent to 15 mcg Cholecalciferol) Calcium (as Calcium Carbonate and Calcium Hydrogen Phosphate Anhydrous)
Magnesium (as Oxide) Potassium (as Sulfate) Selenium (as Sodium Selenate) Iron (as Ferrous Fumarate) Phosphorus Manganese (as Sulfate Monohydrate)
Lycopene Lutein Copper (as Sulfate Anhydrous) Iodine (as Potassium lodide) Zinc (as Oxide) Chromium (as Chloride)
2.18 mg
2.18 mg 400 mcg 45 mcg 25 mcg 22 mcg 600 IU
600 mcg 500 mcg 500 meg 150 mcg 45 mcg
35 mcg
200 mg
|
Film-Coated Tablet
|
Vitamins/Minerals
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
18 April 2022
|
18 April 2027
|
| View |
|
HRP-516
|
Paracetamol
|
Remol 120
|
120 mg/5 mL
|
Oral Suspension
|
Analgesic / Antipyretic
|
Rhydburg Pharmaceuticals Limited
|
India
|
Initial
|
18 April 2022
|
18 April 2027
|
| View |
DRP-11701_PI_01.pdf
|
DRP-11701
|
Fusidic Acid
|
Fusadoc
|
20 mg/g (2% w/w)
|
Topical Cream
|
Antibacterial
|
Rhydburg Pharmaceuticals Ltd.
|
India
|
Initial
|
18 April 2022
|
18 April 2027
|
| View |
|
DR-XY47950
|
Azacitidine
|
Maturus
|
100 mg
|
Lyophilized Powder for Injection (S.C./1.V.)
|
Antineoplastic (Pyrimidine analogues)
|
Laboratorio Kemex S.A.
|
Argentina
|
Monitored Release
|
20 April 2022
|
20 April 2027
|
| View |
|
DR-XY47951
|
Bendamustine hydrochloride (as monohydrate)
|
Benzimir
|
25 mg
|
Lyophilized Powder for Injection (I.V. Infusion)
|
Antineoplastic Agent (Nitrogen Mustard Analogue)
|
Laboratorio Kemex S.A.
|
Argentina
|
Monitored Release
|
20 April 2022
|
20 April 2027
|
| View |
|
DR-XY47952
|
Bendamustine hydrochloride (as monohydrate)
|
Benzimir
|
100 mg
|
Lyophilized Powder for Injection (1.V.
Infusion)
|
Antineoplastic Agent (Nitrogen Mustard Analogue)
|
Laboratorio Kemex S.A.
|
Argentina
|
Monitored Release
|
20 April 2022
|
20 April 2027
|