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DR-XY48013
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Irinotecan hydrochloride
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Irican
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20 mg/mL
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Solution for IV Infusion
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Antineoplastic
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Jiangsu Hengrui Medicine Co., Ltd.
|
China
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Initial
|
12 May 2022
|
12 May 2027
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View |
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DR-XY48014
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Salbutamol (as sulfate) + Guaifenesin
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Salbucof-G
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1 mg/50 mg per 5 mL
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Syrup (Blackcurrant Flavor)
|
Bronchodilator / Expectorant
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Y.S.P. Industries (M) Sdn. Bhd.
|
Malaysia
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Initial
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12 May 2022
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12 May 2027
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DR-XY48015
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Levetiracetam
|
Setam
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100 mg/mL (500 mg/5 mL)
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Solution for Injection (I.V. Infusion)
|
-
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Baxter Pharmaceuticals India Private Limited
|
India
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Initial
|
16 May 2022
|
16 May 2027
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View |
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DR-XY48016
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Salmeterol Xinafoate + Fluticasone Propionate
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Respiro
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25mcg/250mcg
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Metered Dose Inhaler
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Adrenergic/ Corticosteroid
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Deva Holding A.Ş.
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Turkey
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Initial
|
19 May 2022
|
19 May 2027
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View |
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DR-XY48017
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Deflazacort
|
Defal
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30 mg
|
Tablet
|
-
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Faes Farma, S.A.
|
Spain
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Monitored Release
|
16 May 2022
|
16 May 2025
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View |
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DR-XY48018
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Tegoprazan
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K-Cab
|
50 mg
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Film-Coated Tablet
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Proton Pump Inhibitor
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HK Inno.N Corporation
|
Korea
|
Monitored Release
|
18 May 2022
|
18 May 2025
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View |
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DR-XY48019
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Esmolol Hydrochloride
|
Esmobloc
|
10 mg/mL (2.5 g/250 mL)
|
Solution for Injection (IV)
|
Selective Beta Blocking Agent
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Polifarma Ilaç San. Ve Tic. A.S.
|
Turkey
|
Initial
|
18 May 2022
|
18 May 2027
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View |
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DR-XY48020
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Rivaroxaban
|
Riroxator 20
|
20 mg
|
Film-Coated Tablet
|
-
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Torrent Pharmaceuticals Ltd.
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India
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Initial
|
18 May 2022
|
18 May 2027
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View |
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DR-XY48021
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Rivaroxaban
|
Riroxator 15
|
15 mg
|
Film-Coated Tablet
|
-
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Torrent Pharmaceuticals Ltd.
|
India
|
Initial
|
18 May 2022
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18 May 2027
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View |
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DR-XY48022
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Rivaroxaban
|
Riroxator 10
|
10 mg
|
Film-Coated Tablet
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Antithrombotic agent (Direct factor Xa inhibitor)
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Torrent Pharmaceuticals Ltd.
|
India
|
Initial
|
18 May 2022
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18 May 2027
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View |
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DR-XY48023
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Celecoxib
|
Celodix-200
|
200mg
|
Capsule
|
-
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Zim Laboratories Limited
|
India
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Initial
|
18 May 2022
|
18 May 2027
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View |
DR-XY48024_PI_01.pdf
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DR-XY48024
|
Hyoscine N-Butylbromide
|
Copan
|
20mg/mL
|
Solution for Injection (I.M./I.V.)
|
Anticholinergic
|
Duopharma (M) Sdn. Bhd.
|
Malaysia
|
Initial
|
18 May 2022
|
18 May 2027
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View |
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DR-XY48025
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Multivitamins + Mineral
|
Conzace
|
Each softgel capsule contains: Ascorbic Acid (Vitamin C)-500mg dl-Alpha Tocopheryl Acetate (Vitamin E)-100 IU Retinol Palmitate (Vitamin A)-5000 IU Zinc (equivalent to 69mg Zinc Sulfate Monohydrate)-25mg
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Softgel Capsule
|
Vitamins / Mineral
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Belmont Softgel Pharma Corporation
|
Philippines
|
Initial (OTC)
|
20 May 2022
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20 May 2027
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View |
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DR-XY48026
|
Efavirenz
|
None
|
200 mg
|
Capsule
|
Antiviral (Non-Nucleoside Reverse Transcriptase Inhibitor)
|
Micro Labs Limited
|
India
|
Monitored Release
|
19 May 2022
|
19 May 2027
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View |
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DR-XY48027
|
Calcifediol
|
Hidroferol
|
266 mcg Softgel Capsule (equivalent to 15,960 IU of Vitamin D
|
Softgel Capsule
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Vitamin D Analogue
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HC Clover Productos Y Servicios S.L.
|
Spain
|
Monitored Release
|
20 May 2022
|
20 May 2027
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View |
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DR-XY48028
|
Saroglitazar magnesium
|
Lipaglyn
|
4 mg
|
Tablet
|
Dual Peroxisome Proliferator Activated Receptor (PPAR) Alpha/Gamma Agonist
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Cadila Healthcare Limited
|
India
|
Monitored Release
|
20 May 2022
|
20 May 2027
|
View |
DR-XY48029_PI_01.pdf
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DR-XY48029
|
Loxoprofen (as Sodium dihydrate)
|
Loxotop PAP
|
100 mg
|
Medicated Patch
|
Non-steroidal Anti-inflammatory Drug (NSAID)
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Lead Chemical Co., Ltd. (Lead Chemical Co. Ltd.
|
Japan
|
Monitored Release
|
05 July 2022
|
05 July 2027
|
View |
DR-XY48030_PI_01.pdf
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DR-XY48030
|
Esflurbiprofen
|
Locoa
|
40 mg
|
Transdermal Patch
|
-
|
Tokuhon Corporation (Miyashiro Factory)
|
Japan
|
Monitored Release
|
20 May 2022
|
20 May 2027
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View |
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DR-XY480312
|
Permethrin
|
None
|
50 mg/mL (5%)
|
Lotion
|
Scabicide/Pediculoside
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial (OTC]
|
20 May 2022
|
20 May 2027
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View |
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DR-XY48032
|
Fingolimod (As Hydrochloride)
|
Relsis
|
500 mcg
|
Capsule
|
Immunosuppressant
|
Alkem Laboratories Limited
|
India
|
MR-INT
|
24 May 2022
|
24 May 2027
|