| View |
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DR-XY47520
|
Peritoneal dialysis solution with 1.5% Dextrose
|
CAPD/DPCA 17 Stay Safe Link
|
Formulation: Each L of solution contains: Glucose monohydrate -16.5 g (equivalent to 15 g glucose
anhydrous) Calcium chloride dihydrate -183.8 mg
Magnesium chloride hexahydrate-101.7 mg Sodium lactate-3.925 g Sodium chloride-5.786 g
mmol/L : Ca-1.25 Na-134 Mg-0.5
C1-102.5
(S)-lactate-35 Glucose-83.2
|
Solution for Peritoneal Dialysis
|
Peritoneal Dialysis
|
Fresenius Medical Care Production Sdn. Bhd.
|
Malaysia
|
Initial (Reconstruction)
|
22 September 2022
|
09 November 2026
|
| View |
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DR-XY47521
|
Oxytocin
|
Imfetus
|
10 I.U./mL
|
Solution for Injection (I.V.)
|
Posterior Pituitary Lobe Hormone
|
Sterile-Gene Life Sciences (P) Ltd.
|
India
|
Initial
|
09 November 2021
|
09 November 2026
|
| View |
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DR-XY47522
|
Multivitamins + Iron + Rhodiola rosea Root
Paulinia cupana (Guarana) Seeds
|
Enervon Boost
|
Formulation Ascorbic Acid (equivalent to 300mg Sodium Ascorbate) (Vitamin C) Thiamine Mononitrate (Vitamin B1) Riboflavin (Vitamin B2) Pyridoxine Hydrochloride (Vitamin B6) Cyanocobalamin (Vitamin B12) Iron (Carbonyl Iron) Rhodiola rosea Root Paulinia cupana (Guarana) Seeds
50mg 20mg
5mg 4.5mcg
12mg 50mg
50mg
|
Film-coated Tablet
|
-
|
UNILAB, Inc.
|
Philippines
|
-
|
09 November 2021
|
09 November 2026
|
| View |
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DR-XY47523
|
Sodium Ascorbate
|
None
|
500mg (equivalent to 562.43mg Sodium Ascorbate)
|
Capsule
|
-
|
J.M. Tolmann Laboratories Inc.
|
Philippines
|
-
|
09 November 2021
|
09 November 2026
|
| View |
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DR-XY47524
|
Escitalopram (As Oxalate)
|
Jovia
|
20 mg
|
Film-coated Tablet
|
-
|
Bilim Ilaç San. Ve Tic. A.Ş.
|
Turkey
|
-
|
15 November 2021
|
15 November 2026
|
| View |
|
DR-XY47526
|
Ascorbic Acid + Zinc + Cholecalciferol
|
C-Vita + ZN plus D3
|
500 mg (equivalent to 562.43 mg Sodium Ascorbate)/
10 mg (equivalent to 27.5 mg Zinc Sulfate Monohydrate)/ 750 IU
|
Capsule
|
-
|
Northfield Laboratories, Inc.
|
Philippines
|
-
|
10 November 2021
|
10 November 2026
|
| View |
DR-XY47527_PI_01.pdf
|
DR-XY47527
|
Azelastine hydrochloride + Fluticasone propionate
|
Dymista
|
137 mcg/50 mcg per actuation
|
Nasal Suspension
(Spray)
|
Anti-allergic Agent-Corticosteroid Combination
|
Cipla Ltd.
|
India
|
Monitored Release
|
10 November 2021
|
10 November 2026
|
| View |
|
DR-XY47528
|
Cefoxitin Sodium
|
Aefox
|
1g
|
Powder For Injection (IM/IV)
|
-
|
Swiss Pharmaceutical Co., Ltd.
|
Taiwan
|
-
|
12 November 2021
|
12 November 2026
|
| View |
|
DR-XY47529
|
Sitagliptin (as phosphate)
|
Trevia
|
50mg
|
Film-Coated Tablet
|
-
|
Getz Pharma Pvt. Ltd.
|
Pakistan
|
Initial
|
15 November 2021
|
15 November 2026
|
| View |
|
DR-XY47530
|
Sitagliptin (as phosphate)
|
Trevia
|
100mg
|
Film-Coated Tablet
|
-
|
Getz Pharma Pvt. Ltd.
|
Pakistan
|
Initial
|
15 November 2021
|
15 November 2026
|
| View |
|
DR-XY47532
|
Itraconazole
|
Itrazole
|
100 mg
|
Capsule
|
Antifungal
|
Torrent Pharmaceuticals Ltd.
|
India
|
Initial (Reissuance)
|
19 January 2023
|
24 November 2026
|
| View |
|
DR-XY47533
|
Multivitamins
|
Enervon
|
Formulation: Each sugar-coated tablet contains:
Ascorbic Acid-500mg Thiamine Mononitrate (Vit. B3)-50mg Nicotinamide (Vit. B3)-50 mg Riboflavin (Vit. B2)-20 mg
Calcium Pantothenate (Vit. B5)-20mg Pyridoxine Hydrochloride (Vit. B6)-5mg Cyanocobalamin (Vit. B12)-5mcg
|
Sugar-Coated Tablet
|
-
|
Amherst Laboratories, Inc.
|
Philippines
|
-
|
17 November 2021
|
17 November 2026
|
| View |
|
DR-XY47534
|
Multivitamins
|
Enervon
|
Formulation: Each sugar-coated tablet contains:
Ascorbic Acid-500mg Thiamine Mononitrate (Vit. B3)-50mg Nicotinamide (Vit. B3)-50 mg Riboflavin (Vit. B2)-20 mg
Calcium Pantothenate (Vit. B5)-20mg Pyridoxine Hydrochloride (Vit. B6)-5mg Cyanocobalamin (Vit. B12)-5mcg
|
Sugar-Coated Tablet
|
-
|
Amherst Laboratories, Inc.
|
Philippines
|
-
|
17 November 2021
|
17 November 2026
|
| View |
DR-XY47535_PI_01.pdf
|
DR-XY47535
|
Olaparib
|
Lynparza
|
150 mg
|
Film-Coated Tablet
|
-
|
Abbvie Limited
|
Puerto Rico
|
-
|
16 November 2021
|
16 November 2024
|
| View |
DR-XY47536_PI_01.pdf
|
DR-XY47536
|
Olaparib
|
Lynparza
|
100 mg
|
Film-Coated Tablet
|
-
|
Abbvie Limited
|
Puerto Rico
|
-
|
16 November 2021
|
16 November 2024
|
| View |
|
DR-XY47539
|
Phenylpropanolamine
Hydrochloride Chlorpheniramine Maleate + Paracetamol
|
Decolgen Forte 325
|
25mg/2mg/325 mg
|
Tablet
|
-
|
PT. Medifarma Laboratories
|
Indonesia
|
-
|
17 November 2021
|
17 November 2026
|
| View |
|
DR-XY47540
|
Desloratadine
|
Histalor-D
|
5 mg
|
Film-Coated Tablet
|
Antihistamine
|
Sai Mirra Innopharm Pvt. Ltd.
|
India
|
Initial
|
18 November 2021
|
18 November 2026
|
| View |
|
DR-XY47541
|
Moxifloxacin (Hydrochloride)
|
Avelox
|
400 mg/ 250 mL
|
Solution For IV Infusion
|
-
|
Fresenius Kabi Italia S.R.L.
|
Italy
|
-
|
18 November 2021
|
18 November 2026
|
| View |
|
DR-XY47542
|
Pregabalin
|
Valicon
|
75 mg
|
Capsule
|
-
|
Saga Laboratories
|
India
|
-
|
18 November 2021
|
18 November 2026
|
| View |
|
DR-XY47543
|
Pregabalin
|
Convuliz
|
75 mg
|
Capsule
|
-
|
Saga Laboratories
|
India
|
-
|
17 November 2021
|
17 November 2026
|