| View |
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DR-XY48138
|
Propacetamol Hydrochloride
|
Febrex
|
1 g
|
Powder for Injection (IM/IV)
|
-
|
Aju Pharm. Co., Ltd.
|
Korea
|
Initial
|
27 June 2022
|
27 June 2027
|
| View |
DR-XY48139_PI_01.pdf
|
DR-XY48139
|
Ciprofloxacin
|
Ciclodin IV
|
2mg/mL (400mg/200mL)
|
Solution for IV Injection
|
-
|
CJ Healthcare Corporation
|
Korea
|
Initial
|
28 June 2022
|
28 June 2027
|
| View |
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DR-XY48140
|
Ciprofloxacin
|
Ciclodin IV
|
2 mg/mL (200 mg/100 mL)
|
Solution for IV Injection
|
Antibacterial (Fluoroquinolone)
|
HK inno.N Corporation
|
Korea
|
Initial (Correction)
|
26 June 2024
|
28 June 2027
|
| View |
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DR-XY48141
|
Montelukast (as sodium) + Levocetirizine Hydrochloride
|
Montior
|
10 mg/5 mg
|
Film Coated Tablet
|
Leukotriene Receptor Antagonist/ Antihistamine
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial
|
29 June 2022
|
29 June 2027
|
| View |
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DR-XY48142
|
Multivitamins + Choline
|
Natures Plus (Baby Plex)
|
N/A
|
Oral Drops (Orange Flavor)
|
Vitamins
|
Natural Organics Laboratories, Inc.
|
United States of America
|
Initial (OTC)
|
28 June 2022
|
28 June 2027
|
| View |
DR-XY48143_PI_01.pdf
|
DR-XY48143
|
Valproic Acid
|
Depakene
|
250mg/5mL
|
Syrup
|
-
|
P.T. Abbott Indonesia
|
Indonesia
|
Initial
|
28 June 2022
|
28 June 2027
|
| View |
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DR-XY48144
|
Isopropanol + Benzalkonium Chloride
|
Zeptagen
|
63 g/0.025 g per 100 g
|
Solution
|
Disinfectant/Antiseptic
|
Greatstar Laboratories
|
Philippines
|
Initial [OTC] (Correction)
|
22 December 2022
|
29 June 2027
|
| View |
DR-XY48145_PI_01.pdf
|
DR-XY48145
|
Ritonavir
|
Tonavir
|
100 mg
|
Film Coated Tablet
|
Antiretroviral (Protease Inhibitor)
|
Hetero Labs Limited
|
India
|
Monitored Release
|
29 June 2022
|
29 June 2027
|
| View |
|
DR-XY48146
|
Sildenafil (As Citrate)
|
Sildefar
|
100 mg
|
Film-Coated Tablet
|
Phosphodiesterase-5 (PDE5) Inhibitor
|
Zim Laboratories Limited
|
India
|
Initial
|
01 July 2022
|
01 July 2027
|
| View |
DR-XY48147_PI_01.pdf
|
DR-XY48147
|
Drospirenone
|
Slinda
|
4 mg
|
Film-Coated Tablet
|
-
|
Laboratorios Leon Farma, S.A.
|
Spain
|
Monitored Release
|
30 June 2022
|
30 June 2027
|
| View |
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DR-XY48148
|
Gadoteric Acid
|
Cyclolux
|
0.5 mmol/mL (equivalent to 279.32 mg/mL)
|
Solution
for Injection (IV)
|
Paramagnetic Contrast Media
|
Sanochemia Pharmazeutika AG
|
Austria
|
Initial
|
30 June 2022
|
30 June 2027
|
| View |
|
DR-XY48149
|
Amino Acids
|
Aminoven
|
0.1
|
Solution for IV Infusion
|
Parenteral Nutrition
|
Fresenius Kabi Austria GmbH
|
Austria
|
Initial (correction)
|
09 February 2023
|
30 June 2027
|
| View |
DR-XY48150_PI_01.pdf
|
DR-XY48150
|
Abiraterone Acetate
|
Abirone
|
250 mg
|
Tablet
|
-
|
Aziant Drug Research Solutions Pvt. Ltd.
|
India
|
Initial
|
30 June 2022
|
30 June 2027
|
| View |
|
DR-XY48151
|
Emtricitabine + Tenofovir Disoproxil Fumarate
|
Teno-Em
|
200 mg/300 mg
|
Film-Coated Tablet
|
Direct Acting Antivirals (Combinations for treatment
of HIV Infections)
|
The Government Pharmaceutical Organization
|
Thailand
|
Monitored Release
|
30 June 2022
|
30 June 2027
|
| View |
|
DR-XY48152
|
Cabergoline
|
Caberline
|
500 mcg
|
Tablet
|
Prolactine Inhibitor
|
Sun Pharmaceutical Industries Limited
|
India
|
Monitored Release (Reconstruction)
|
24 May 2024
|
01 July 2027
|
| View |
|
DR-XY48153
|
Olmesartan Medoxomil + Amlodipine +
Hydrochlorothiazide
|
Olmat- AMH
|
40 mg/10 mg/25 mg
|
Tablets
|
Antihypertensive (Angiotensin II Receptor Blocker/ Calcium Channel Blocker/ Diuretic)
|
Micro Labs Limited
|
india
|
Monitored Release
|
01 July 2022
|
01 July 2027
|
| View |
|
DR-XY48154
|
Sevelamer Carbonate
|
Lophos
|
800mg
|
Film-Coated Tablet
|
Hypophosphatemic Agent
|
Pharmathen International SA
|
Greece
|
Initial
|
01 July 2022
|
01 July 2027
|
| View |
|
DR-XY48155
|
Ropinirole (as hydrochloride)
|
Kinetica
|
2 mg
|
Prolonged Release Tablet
|
Anti-Parkinson Drug (Dopamine Agonist)
|
Krka, D.D., Novo Mesto
|
Slovenia
|
Monitored Release
|
01 July 2022
|
01 July 2025
|
| View |
|
DR-XY48156
|
Teicoplanin
|
Ticoray
|
200mg
|
Powder For Injection (IV/IM))
|
Antibacterial
|
Mylan Laboratories Limited (Sterile Products Division)
|
India
|
Initial
|
01 July 2022
|
01 July 2027
|
| View |
|
DR-XY48157
|
Dabigatran etexilate (as mesilate)
|
Dabitrin 150
|
150 mg
|
Capsule
|
Antithrombotic Agent (Direct Thrombin Inhibitor)
|
Hetero Labs Limited (Unit III)
|
India
|
Initial (Variation)
|
14 March 2024
|
14 March 2029
|