| View |
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DR-XY48649
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Sterile Water For Injection
|
None
|
50mL in 50mL, 100mL in 100mL; 500mL in 500mL; 1000mL in 1000mL
|
Solution For Injection
|
-
|
General Hospital Products Public Co., Ltd.
|
Thailand
|
Initial
|
13 March 2023
|
13 March 2028
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| View |
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DR-XY48650
|
Lactated Ringer's Solution
|
None
|
600 mg/30 mg/20 mg/310 mg per 100 mL
|
Solution for
IV Infusion
|
-
|
A.N.B. Laboratories Co., Ltd.
|
Thailand
|
Initial
|
14 March 2023
|
14 March 2028
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| View |
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DR-XY48651
|
Candesartan cilexetil
|
Hyperest
|
16 mg
|
Tablet
|
-
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Laboratorios Liconsa, S.A.
|
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Initial
|
24 March 2023
|
24 March 2028
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| View |
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DR-XY48653
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Ascorbic Acid + Colecalciferol + Zinc
|
Redoxon
|
1 g/400 IU/10 mg
|
Effervescent Tablet (Orange Flavour)
|
-
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PT. Bayer Indonesia
|
Indonesia
|
Initial (OTC)
|
15 March 2023
|
15 March 2028
|
| View |
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DR-XY48654
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Mutivitamins + Zinc
|
Enervon Z+
|
Each Film-Coated Tablet contains:
Ascorbic Acid (Vitamin C)
(equivalent to 568.11 mg of Sodium Ascorbate) 500 mg
Thiamine Mononitrate (Vitamin B1) 50 mg
Riboflavin (Vitamin B2) 20 mg
Niacinamide (Vitamin B3) 20 mg
Calcium Pantothenate (Vitamin B5) 20 mg
Pyridoxine Hydrochloride (Vitamin B6) 5 mg
Cyanocobalamin (Vitamin B12)4 mcg
d-Alpha-Tocopheryl Acid Succinate
(Vitamin E) 11 IU
Zinc Sulfate
(equivalent to 27.5 mg Zinc Sulfate monohydrate) 10 mg
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Film-Coated Tablet
|
-
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UNILAB, Inc.
|
Philippines
|
Initial
|
15 March 2023
|
15 March 2028
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| View |
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DR-XY48655
|
Evogliptin (as tartrate)
|
Suganon
|
5 mg
|
Film-Coated Tablet
|
-
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Dong-A ST Co., Ltd.
|
Korea
|
Monitored Release
|
16 March 2023
|
16 March 2028
|
| View |
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DR-XY48656
|
Aripiprazole
|
Aripraz 5
|
5 mg
|
Film Coated Tablet
|
-
|
Unison Laboratories Co., Ltd.
|
Thailand
|
Initial
|
16 March 2023
|
16 March 2028
|
| View |
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DR-XY48657
|
Escitalopram (as oxalate)
|
Ciklox
|
20 mg
|
Film-Coated Tablet
|
-
|
Kusum Healthcare Pvt. Ltd.
|
India
|
Initial
|
17 March 2023
|
17 March 2028
|
| View |
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DR-XY48658
|
Alfuzosin Hydrochloride
|
Muraxal
|
10 mg
|
Extended-Release Tablet
|
-
|
Micro Labs Limited
|
India
|
Initial
|
20 March 2023
|
20 March 2028
|
| View |
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DR-XY48659
|
Indacaterol (as acetate) + Glycopyrronium (as bromide)
+ Mometasone Furoate
|
None
|
150 mcg/ 50 mcg/ 160 mcg
|
Powder for Inhalation in Hard Capsule
|
-
|
Novartis Pharma Stein AG
|
|
Monitored Release
|
21 March 2023
|
21 March 2028
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| View |
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DR-XY48660
|
Dolutegravir (as sodium) + Lamivudine + Tenofovir
disoproxil fumarate
|
None
|
50 mg/300 mg/300 mg
|
Film-Coated Tablet
|
-
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Aurobindo Pharma Limited (Unit VII)
|
|
Monitored Release (Re-application)
|
21 March 2023
|
21 March 2026
|
| View |
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DR-XY48661
|
Cloxacillin (as sodium)
|
Cloxispa-250
|
250 mg/5 mL
|
Powder for Oral Solution
|
-
|
Sparsh Bio-tech Pvt., Ltd.
|
|
Initial
|
22 March 2023
|
22 March 2028
|
| View |
DR-XY48662_PI_01.pdf
|
DR-XY48662
|
Teriflunomide
|
None
|
14mg
|
Tablet
|
-
|
Shilpa Medicare Limited (Unit-4, Pharmaceutical Formulations Sez)
|
|
Monitored Release (Reapplication)
|
22 March 2023
|
22 March 2028
|
| View |
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DR-XY48663
|
Moxifloxacin (as hydrochloride)
|
Pol-Moxi
|
400 mg/ 250 mL
|
Solution for I.V. Infusion
|
-
|
Polifarma Ilac San Ve. Tic. A.S.
|
|
Initial
|
22 March 2023
|
22 March 2028
|
| View |
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DR-XY48664
|
Alpha Ketoanalogues + Essential Amino Acids
|
Renalog Ds
|
Formulation
Each film-coated tablet contains:
Calcium-4-methyl-2-oxovalerate (a-ketoanalogue of leucine, calcium salt).
Calcium-3-methyl-2-oxobutyrate (a-ketoanalogue of valine, calcium salt)..
Calcium-2-oxo-3-phenylpropionate (a-ketoanalogue of phenylalanine, calcium salt).
Calcium-3-methyl-2-oxovalerate (a-ketoanalogue of isoleucine, calcium salt)..
202 mg
172 mg
.... 136 mg
134 mg
Calcium-DL-2-hydroxy-4-(methylthio)-butyrate (a-hydroxyanalogue of methionine, calcium salt)... 118 mg
L-Lysine acetate....
L-Threonine.....
L-Histidine..
L-Tyrosine....
L-Tryptophan.....
Total Nitrogen Content..
210 mg
106 mg
76 mg
60 mg
46 mg
72 mg
|
Film-Coated Tablet
|
-
|
Pharose Remedies Limited
|
India
|
Monitored Release
|
04 October 2023
|
04 October 2028
|
| View |
DR-XY48665_PI_01.pdf
|
DR-XY48665
|
Inclisiran (as sodium)
|
Sybrava
|
284 mg/1.5 mL
|
Solution for Injection (SC)
|
-
|
Corden Pharma Societa' Per Azioni
|
|
Monitored Release
|
23 March 2023
|
23 March 2028
|
| View |
|
DR-XY48666
|
Lenalidomide
|
Lenalid 25
|
25 mg
|
Capsule
|
-
|
Natco Pharma Limited Pharma Division
(Unit IV and V)
|
|
Monitored Release
|
27 March 2023
|
27 March 2028
|
| View |
|
DR-XY48667
|
Lenalidomide
|
Lenalid 15
|
15 mg
|
Capsule
|
-
|
Natco Pharma Limited Pharma Division
(Unit IV and V)
|
|
Monitored Release
|
27 March 2023
|
27 March 2028
|
| View |
|
DR-XY48668
|
Lenalidomide
|
Lenalid 10
|
10 mg
|
Capsule
|
-
|
Natco Pharma Limited Pharma Division
(Unit IV and V)
|
|
Monitored Release
|
27 March 2023
|
27 March 2028
|
| View |
|
DR-XY48669
|
Lenalidomide
|
Lenalid 5
|
5 mg
|
Capsule
|
-
|
Natco Pharma Limited Pharma Division
(Unit IV and V)
|
|
Monitored Release
|
27 March 2023
|
27 March 2028
|