| View |
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DR-XY48096
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Monobasic Sodium Phosphate + Dibasic Sodium
Phosphate
|
Phospho-Soda
|
24.4 g / 10.8 g per 45 mL
|
Oral Solution
(Ginger Lemon Flavor)
|
Laxative
|
Casen Recordati, S.L.
|
Spain
|
Initial
|
08 June 2022
|
08 June 2027
|
| View |
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DR-XY48097
|
Sevelamer Carbonate
|
Sevela
|
800mg
|
Film Coated Tablet
|
Phosphate Binder
|
Chen Ho Pharmaceutical Co., Ltd. (Sinying Plant)
|
Taiwan
|
Initial
|
08 June 2022
|
08 June 2027
|
| View |
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DR-XY48098
|
Bisoprolol fumarate
|
None
|
5 mg
|
Film-Coated Tablet
|
Beta-Adrenoceptor Blocker
|
United International Pharma Co., Ltd.
|
Vietnam
|
Initial
|
09 June 2022
|
09 June 2027
|
| View |
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DR-XY48099
|
Febuxostat
|
None
|
40 mg
|
Film-Coated Tablet
|
Antigout Preparation
|
Ajanta Pharma Limited
|
India
|
Initial (Correction)
|
17 November 2023
|
09 June 2027
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| View |
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DR-XY48100
|
Vancomycin (as hydrochloride)
|
Vancover
|
250 mg
|
Capsule
|
Antibacterial (Glycopepure
|
Orient Pharma Co., Ltd.
|
Taiwan
|
Monitored Release
|
09 June 2022
|
09 June 2025
|
| View |
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DR-XY48102
|
Losartan Potassium + Hydrochlorothiazide
|
Saranto-H
|
100 mg/25 mg
|
Film coated tablet
|
Angiotensin II Receptor blocker (ARB)/ Diuretic
|
Aurobindo Pharma Limited (Unit III)
|
India
|
Initial
|
09 June 2022
|
09 June 2027
|
| View |
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DR-XY48103
|
Clotrimazole + Betamethasone (as dipropionate) +
Gentamicin (as sulfate)
|
Tribact
|
0 mg/ 1 mg/ 500 mcg (1%/ 0.1%/ 0.05% w/w)
|
Cream
|
Antifungal/ Corticosteroid/ Antibacterial
(Aminoglycoside)
|
Front Pharmaceutical PLC
|
China
|
Initial
|
10 June 2022
|
10 June 2027
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| View |
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DR-XY48104
|
Remifentanil (as hydrochloride)
|
Remifen
|
1 mg
|
Lyophilized Powder for Solution for Injection or Infusion (IV)
|
-
|
Laboratorios Normon, S.A.
|
Spain
|
Initial
|
26 August 2022
|
26 August 2027
|
| View |
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DR-XY48105
|
Ascorbic Acid + Rosa carnina (Rose Hips Fruit)
|
None
|
500mg / 40mg
|
Tablet
|
-
|
Now Foods
|
U.S.A.
|
Initial (Correction)
|
09 January 2024
|
13 June 2027
|
| View |
DR-XY48106_PI_01.pdf
|
DR-XY48106
|
Rosuvastatin (as calcium) & Ezetimibe
|
Lypstaplus
|
20 mg/10 mg
|
film coated tablet
|
-
|
Medreich Limited (Unit 3)
|
India
|
Monitored Release
|
14 June 2022
|
14 June 2027
|
| View |
DR-XY48107_PI_01.pdf
|
DR-XY48107
|
Rosuvastatin (as calcium) & Ezetimibe
|
Lypstaplus
|
10 mg/10 mg
|
film coated tablet
|
-
|
Medreich Limited (Unit 3)
|
India
|
Monitored Release
|
14 June 2022
|
14 June 2027
|
| View |
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DR-XY48108
|
Efavirenz
|
Avirenz
|
600 mg
|
Film-Coated Tablet
|
Antiviral
|
The Government Pharmaceutical Organization
|
Thailand
|
Initial
|
16 June 2022
|
16 June 2027
|
| View |
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DR-XY48109
|
Amlodipine (as besilate)
|
None
|
5 mg
|
Tablet
|
Calcium Channel Blocker
|
The Government Pharmaceutical Organization (Production Plant I-GPO Thanyaburi)
|
Thailand
|
Initial
|
17 June 2022
|
17 June 2027
|
| View |
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DR-XY48111
|
Rasagiline (as tartrate)
|
None
|
1 mg
|
Tablet
|
Dopaminergic Agent (Monoamine Oxidase B Inhibitor)
|
Lacer, S.A.
|
Spain
|
Initial
|
16 June 2022
|
16 June 2027
|
| View |
DR-XY48112_PI_01.pdf
|
DR-XY48112
|
Granisetron (as hydrochloride)
|
Kytron
|
1mg/mL (3 mg/3mL)
|
Solution for Injection/Infusion
(I.M./I.V.)
|
Antiemetic and Antinauseant
|
Duopharma (M) Sdn. Bhd.
|
Malaysia
|
Initial (Correction)
|
18 October 2022
|
30 June 2027
|
| View |
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DR-XY48113
|
Iron (As Iron Sucrose)
|
Ranofer
|
20 mg/mL (100mg/5 mL)
|
Solution for Injection (I.V.)
|
Antianemic preparation
|
Duopharma (M) Sdn. Bhd.
|
Malaysia
|
Initial
|
17 June 2022
|
17 June 2027
|
| View |
DR-XY48114_PI_01.pdf
|
DR-XY48114
|
Tadalafil
|
Tadafil 2.5
|
2.5 mg
|
Film-Coated Tablet
|
Phosphodiesterase Type-5 Inhibitor (Urological)
|
Hetero Labs Limited
|
India
|
Monitored Release (MR)
|
17 June 2022
|
17 June 2027
|
| View |
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DR-XY48115
|
Meloxicam
|
Mobic®
|
15 mg
|
Tablet
|
Non-Steroidal Anti-inflammatory Drug (NSAID)
|
Rottendorf Pharma GmbH
|
Germany
|
Initial
|
17 June 2022
|
17 June 2027
|
| View |
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DR-XY48116
|
Meloxicam
|
Mobic®
|
7.5 mg
|
Tablet
|
-
|
Rottendorf Pharma GmbH
|
Germany
|
Initial
|
17 June 2022
|
17 June 2027
|
| View |
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DR-XY48117
|
Tranexamic Acid
|
Tafixyl
|
500 mg
|
Film-Coated Tablet
|
Antifibrinolytic
|
Labiana Pharmaceuticals, S.L.U
|
Spain
|
Initial
|
17 June 2022
|
17 June 2027
|