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