| View |
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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
|
| View |
|
DR-XY47953
|
Levetiracetam
|
Epilept
|
500mg/5mL
|
Concentrate For Solution For Infusion
|
Gynecological Anti-infective and Antiseptic
|
Maiva Pharma Pvt. Ltd.
|
India
|
Initial
|
21 April 2022
|
21 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 |
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DR-XY47955
|
Cefuroxime (as axetil)
|
None
|
500 mg
|
Film-Coated Tablet
|
Antibacterial (Cephalosporin)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
22 April 2022
|
22 April 2027
|
| View |
|
DR-XY47956
|
Cefuroxime (As Axetil)
|
Rovix
|
500 mg
|
Film-Coated Tablet
|
Antibacterial (Cephalosporin)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
22 April 2022
|
22 April 2027
|
| View |
|
DR-XY47957
|
Cefuroxime (As Axetil)
|
Medzyme
|
500 mg
|
Film-Coated Tablet
|
Antibacterial (Cephalosporin)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
22 April 2022
|
22 April 2027
|
| View |
|
DR-XY47958
|
Cefuroxime (As Axetil)
|
Zefur
|
500 mg
|
Film Coated Tablet
|
Antibacterial (Cephalosporin)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
22 April 2022
|
22 April 2027
|
| View |
DR-XY47959_PI_01.pdf
|
DR-XY47959
|
Sevelamer Carbonate
|
Nephvela
|
800mg
|
Film Coated Tablet
|
Phosphate Binder
|
Synthon Hispania SL
|
Spain
|
Monitored Release
|
22 April 2022
|
22 April 2027
|
| View |
|
DR-XY47960
|
Levonorgestrel + Ethinylestradiol
|
Conchoice
|
150 mcg/30 mcg
|
Tablet
|
Hormonal Contraceptive
|
Sun Pharmaceutical Industries Ltd.
|
India
|
Initial
|
27 April 2022
|
27 April 2027
|
| View |
|
DR-XY47961
|
Simvastatin
|
Vastilan
|
40 mg
|
Film-Coated Tablet
|
Lipid Modifying Agent (HMG COA Reductase Inhibitor)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
25 April 2022
|
25 April 2027
|
| View |
|
DR-XY47962
|
Simvastatin
|
Vastilan
|
20 mg
|
Film-Coated Tablet
|
Lipid Modifying Agent (HMG COA Reductase Inhibitor)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
25 April 2022
|
25 April 2027
|
| View |
|
DR-XY47963
|
Simvastatin
|
Forcad
|
10 mg
|
Film-Coated Tablet
|
Lipid Modifying Agent (HMG COA Reductase Inhibitor
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
25 April 2022
|
25 April 2027
|
| View |
|
DR-XY47964
|
Levodopa + Carbidopa
|
None
|
250 mg / 25 mg
|
Tablet
|
Anti-Parkinson Drug (Dopaminergic Agent)
|
Micro Labs Limited
|
India
|
Initial
|
25 April 2022
|
25 April 2027
|
| View |
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DR-XY47965
|
Lactated Ringer'S Solution (Ringer'S Lactate)
|
None
|
600mg/310mg/30mg/20mg
|
Solutiuon for Intravenous Infusion
|
-
|
A.N.B. Laboratories Co., Ltd.
|
Thailand
|
-
|
26 April 2022
|
26 April 2027
|
| View |
|
DR-XY47966
|
Iron + Zinc + Vitamin B-Complex
|
Adfer
|
300mg/ 1.5mg/ 1mg/ 7.5mcg/ 20mg
|
Softgel Capsule
|
Minerals / Vitamins
|
Renown Pharmaceuticals Pvt. Ltd.
|
India
|
Initial (OTC)
|
28 April 2022
|
28 April 2027
|
| View |
|
DR-XY47967
|
Risdiplam
|
Evrysdi
|
0.75 mg/mL
|
Powder For Oral Solution
|
-
|
F. Hoffmann-La Roche, Ltd.
|
Switzerland
|
Monitored Release
|
26 April 2022
|
26 April 2027
|
| View |
|
DR-XY47968
|
Ascorbic Acid + Zinc
|
Primo C Plus Zinc
|
500 mg (equivalent to 562.5 mg Sodium Ascorbate)/ 10 mg (equivalent to 27.5 mg Zinc Sulfate Monohydrate)
|
Capsule
|
Vitamin/Mineral
|
Sydenham Laboratories, Inc,
|
Philippines
|
Initial (OTC] (Correction)
|
10 August 2022
|
06 May 2027
|
| View |
|
DR-XY47969
|
Triamcinolone Acetonide
|
Tricort
|
1 mg/mL (0.1% w/v)
|
Scalp Lotion
|
Topical Corticosteroid
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
27 April 2022
|
27 April 2027
|
| View |
|
DR-XY47970
|
Drospirenone + Ethinylestradiol
|
Yanci-30
|
3mg / 30mcg
|
Tablet
|
Hormonal Contraceptive
|
Mylan Laboratories Ltd.
|
India
|
Initial
|
04 May 2022
|
04 May 2027
|