| View |
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DR-XY48057
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Losartan potassium + Hydrochlorothiazide
|
Medlosar-Plus 25
|
100mg/25mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker (ARB)/Diuretic
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial
|
27 May 2022
|
27 May 2027
|
| View |
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DR-XY48058
|
Finasteride
|
Prostride
|
5 mg
|
Film Coated Tablet
|
Testosterone-5-Alpha Reductase Inhibitors
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Alkem Laboratories Limited
|
India
|
Initial
|
27 May 2022
|
27 May 2027
|
| View |
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DR-XY48059
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Pemetrexed
|
Pemexbil
|
500 mg
|
Lyophilized Powder for Intravenous (I.V.) Infusion
|
Antineoplastic (Folic Acid Analogue)
|
SP Accure Labs Pvt. Ltd.
|
India
|
Initial
|
30 May 2022
|
30 May 2027
|
| View |
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DR-XY48060
|
Pemetrexed (as disodium)
|
Pemexbil
|
100 mg
|
Lyophilized Powder for Intravenous (I.V.) Infusion
|
Antineoplastic (Folic Acid Analogue)
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SP Accure Labs Pvt. Ltd.
|
India
|
Initial
|
02 June 2022
|
02 June 2027
|
| View |
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DR-XY48062
|
Deflazacort
|
Defal
|
6 mg
|
Tablet
|
-
|
Faes Farma, S.A.
|
Spain
|
Monitored Release
|
27 May 2022
|
27 May 2025
|
| View |
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DR-XY48063
|
Atorvastatin (as Calcium) + Fenofibrate
|
Fenostat
|
20 mg/ 160mg
|
Film-Coated Tablet
|
-
|
Ajanta Pharma Limited
|
India
|
Initial (from Monitored Release)
|
30 May 2022
|
16 March 2025
|
| View |
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DR-XY48064
|
Atorvastatin (as Calcium) + Fenofibrate
|
Fenostat
|
10mg/160mg
|
Film-Coated Tablet
|
-
|
Ajanta Pharma Limited
|
India
|
Initial (from Monitored Release)
|
30 May 2022
|
16 March 2025
|
| View |
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DR-XY48065
|
Famciclovir
|
Penvir 750
|
750mg
|
Film Coated Tablet
|
Antiviral (Nucleoside/nucleotide excl. reverse transcriptase inhibitor)
|
Hetero Labs Limited (Unit V)
|
India
|
Monitored Release
|
21 June 2022
|
21 June 2025
|
| View |
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DR-XY48066
|
Emedastine (as Difumarate)
|
Allesaga Patch
|
8 mg
|
Transdermal Patch
|
Antihistamine
|
Hisamitsu Pharmaceutical Co., Inc. (Tosu Plant)
|
Japan
|
Monitored Release
|
30 May 2022
|
30 May 2025
|
| View |
|
DR-XY48067
|
Sevelamer Carbonate
|
Selaglob 800
|
800mg
|
Film-Coated Tablet
|
Drug for Treatment of Hyperkalemia/ Hyperphosphatemia
|
Globela Pharma Private Limited
|
India
|
Initial
|
30 May 2022
|
30 May 2027
|
| View |
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DR-XY48068
|
Testosterone
|
Androgel
|
1 mg/g (1% w/w)
|
Transdermal Gel
|
Androgen [3-oxoandrosten (4) derivative]
|
Delpharm Drogenbos S.A.
|
Belgium
|
Monitored Release (Re-application)
|
30 May 2022
|
30 May 2027
|
| View |
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DR-XY48069
|
Avanafil
|
Spedra
|
200 mg
|
Tablet
|
-
|
Sanofi Winthrop Industrie
|
France
|
Monitored Release
|
07 June 2022
|
07 June 2027
|
| View |
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DR-XY48070
|
Avanafil
|
Spedra
|
100 mg
|
Tablet
|
Phosphodiesterase-5 Inhibitor
|
Sanofi Winthrop Industrie
|
France
|
Monitored Release
|
07 June 2022
|
07 June 2027
|
| View |
|
DR-XY48071
|
Pregabalin + Methylcobalamin (Vitamin B12)
|
Neurica-M 150
|
150 mg/750 mcg
|
Capsule
|
Antiepileptics
|
Micro Labs Limited
|
India
|
Monitored Release
|
28 June 2022
|
28 June 2027
|
| View |
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DR-XY48072
|
Pregabalin + Methylcobalamin (Vitamin B12)
|
Neurica-M 75
|
75 mg/750 mcg
|
Capsule
|
Antiepileptics
|
Micro Labs Limited
|
India
|
Monitored Release
|
28 June 2022
|
28 June 2027
|
| View |
|
DR-XY48073
|
Azacitidine
|
Xpreza
|
100mg
|
Lyophilized Powder for Injection (I.V./S.C.)
|
Antineoplastic (Pyrimidine Analogue)
|
Natco Pharma Limited
|
India
|
Monitored Release (Reconstruction)
|
11 November 2022
|
31 May 2027
|
| View |
|
DR-XY48075
|
Ascorbic Acid
|
Vera - C
|
500 mg
|
Tablet
|
Vitamin
|
Vonwelt Inc.
|
Philippines
|
Initial (OTC)
|
08 June 2022
|
08 June 2027
|
| View |
|
DR-XY48076
|
Montelukast (as sodium) + Levocetirizine hydrochloride
|
Molev
|
10 mg/ 5 mg
|
Film Coated Tablet
|
Leukotriene Receptor Antagonist
|
Cadila Healthcare Limited
|
India
|
Initial
|
01 June 2022
|
01 June 2027
|
| View |
|
DR-XY48077
|
Dexketoprofen (as trometamol)
|
Voxib
|
25 mg/ml
|
Solution for Injection (1. M./1.V.) or
Concentrate for Solution for I. V. Infusion
|
Non-steroidal
Anti-inflammatory/Antirheumatic (Propionic Acid Derivative)
|
PT. Novell Pharmaceutical Laboratories
|
Indonesia
|
Initial
|
01 June 2022
|
01 June 2027
|
| View |
DR-XY48078_PI_01.pdf
|
DR-XY48078
|
Azacitidine
|
Azacytin
|
100 mg
|
Lyophilized Powder For Injection (I.V/S.C)
|
-
|
Dr. Reddy's Laboratories Ltd.
|
India
|
Monitored Release
|
01 June 2022
|
01 June 2025
|