| View |
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DR-XY47910
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Salmeterol Xinafoate + Fluticasone Propionate
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Respiro
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25mcg/50mcg
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Metered Dose Inhaler
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Adrenergic / Corticosteroid
|
Deva Holding A.Ş.
|
Turkey
|
Initial
|
08 April 2022
|
08 April 2027
|
| View |
DR-XY47912_PI_01.pdf
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DR-XY47912
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Olmesartan Medoxomil + Amlodipine (as besilate)
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Alzor CCB
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20mg / 10mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blockers (ARBs) and Calcium
Channel Blockers
|
Ajanta Pharma Limited
|
India
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Initial [from Monitored Release status] [Correction]
|
02 September 2022
|
06 April 2027
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| View |
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DR-XY47913
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Pemetrexed (As Disodium)
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Pemex
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500 mg
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Lyophilized Powder for Injection (IV)
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Antineoplastic Agents (Folic Acid Analogues)
|
Jiangsu Hansoh Pharmaceutical Co., Ltd.
|
China
|
Initial
|
07 April 2022
|
07 April 2027
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| View |
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DR-XY47914
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Pemetrexed
|
Pemex
|
100 mg
|
Lyophilized Powder for Injection (IV)
|
Antineoplastic Agents (Folic Acid Analogues)
|
Jiangsu Hansoh Pharmaceutical Co., Ltd.
|
China
|
Initial
|
07 April 2022
|
07 April 2027
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| View |
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DR-XY47915
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Sevelamer Carbonate
|
Renvex
|
800 mg
|
Film-Coated Tablet
|
Drugs for treatment of hyperkalemia
hyperphosphatemia
|
Haimen Pharma Inc.
|
China
|
Initial
|
11 April 2022
|
11 April 2027
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| View |
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DR-XY47916
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Acetylcysteine
|
None
|
200 mg
|
Powder for Oral Solution
|
Mucolytic
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
08 April 2022
|
08 April 2027
|
| View |
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DR-XY47917
|
Acetylcysteine
|
Flumistin
|
200 mg
|
Powder For Oral Solution
|
Mucolytic
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
08 April 2022
|
08 April 2027
|
| View |
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DR-XY47918
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Docetaxel (as Trihydrate)
|
Admoxel-120
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120mg/3mL
|
Concentrate Solution for IV Infusion
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Antineoplastic
|
Admac Lifesciences
|
India
|
Initial
|
08 April 2022
|
08 April 2027
|
| View |
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DR-XY47919
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Docetaxel (as Trihydrate)
|
Admoxel- 20
|
20mg/0.5mL
|
Concentrate Solution for IV Infusion
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Antineoplastic
|
Admac Lifesciences
|
India
|
Initial
|
08 April 2022
|
08 April 2027
|
| View |
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DR-XY47920
|
Docetaxel (as Trihydrate)
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Admoxel- 80
|
80mg/2mL
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Concentrate Solution for IV Infusion
|
-
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Admac Lifesciences
|
India
|
-
|
08 April 2022
|
08 April 2027
|
| View |
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DR-XY47921
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Peritoneal Dialysis Solution Low Calcium with 4.25%
Dextrose
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Dianeal PD-4
|
Dextrose hydrous, USP
Sodium chloride, USP
Sodium lactate, USP
Calcium chloride dihydrate, USP
Magnesium chloride hexahydrate, USP
4.25 g 538 mg
448 mg
18.3 mg
5.08 mg
|
Dialysis Solution
|
Peritoneal Dialytic
|
Baxter Manufacturing (Thailand) Co., Ltd.
|
Thailand
|
Initial (Variation
|
24 August 2023
|
24 August 2028
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| View |
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DR-XY47922
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Peritoneal Dialysis Solution Low Calcium with 2.5% Dextrose
|
Dianeal PD-4
|
Formulation:
Each 100 mL contains:
Dextrose hydrous, USP
Sodium chloride, USP
Sodium lactate, USP
Calcium chloride dihydrate, USP
Magnesium chloride hexahydrate, USP
2.5 g 538 mg
448 mg
18.3 mg
5.08 mg
|
Dialysis Solution.
(Intraperitoneal)
|
Peritoneal Dialytic
|
Baxter Manufacturing (Thailand) Co., Ltd.
|
Thailand
|
Initial (Variation)
|
08 September 2023
|
24 August 2028
|
| View |
|
DR-XY47923
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Peritoneal Dialysis Solution Low Calcium with 1.5%
Dextrose
|
Dianeal Pd-4
|
Each 100 mL contains:
Dextrose hydrous, USP
Sodium chloride, USP
Sodium lactate, USP
Calcium chloride dihydrate, USP
Magnesium chloride hexahydrate, USP
1.5 g 538 mg
448 mg
18.3 mg
5.08 mg
|
Dialysis Solution.
|
Peritoneal Dialytic
|
Baxter Manufacturing (Thailand) Co., Ltd.
|
Thailand
|
Initial (Variation)
|
24 August 2023
|
24 August 2028
|
| View |
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DR-XY47924
|
Multivitamins + Mineral
|
Conzace
|
Formulation Each softgel capsule contains: Ascorbic Acid (Vitamin C)-500mg Retinol Palmitate (Vitamin A)-5000 IU dl-Alpha Tocopheryl Acetate (Vitamin E)-100IU Zinc (as Sulfate) -25mg
|
Softgel Capsule
|
Vitamins /Mineral
|
Belmont Softgel Pharma Corporation
|
Philippines
|
Initial (OTC)
|
13 April 2022
|
13 April 2027
|
| View |
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DR-XY47925
|
Pacliatcel
|
None
|
6mg/mL (100mg / 16.7mL)
|
Solution for IV Infusion
|
Antineoplastic
|
Venus Remedies, Limited
|
India
|
Initial
|
13 April 2022
|
13 April 2027
|
| View |
|
DR-XY47926
|
Ascorbic Acid + Zinc + Colecalciferol (Vitamin D3)
|
Immunforte
|
500mg (equivalent to 568.11mg Sodium Ascorbate) /
10mg (equivalent to 27.5mg Zinc Sulfate Monohydrate) / 600 IU
|
Film-Coated Tablet
|
Vitamin/Mineral
|
UNILAB, Inc.
|
Philippines
|
Initial
|
18 April 2022
|
18 April 2027
|
| View |
|
DR-XY47927
|
Zinc
|
None
|
10mg (equivalent to 47.35mg Zinc Picolinate)
|
Film coated Tablet
|
Mineral
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial (OTC)
|
12 April 2022
|
12 April 2027
|
| View |
|
DR-XY47928
|
Peritoneal Dialysis Solution with 4.25% Dextrose
|
CAPD/DPCA 3 Stay Safe Link Solution for Peritoneal Dialysis
|
Each 1000mL contains:
Sodium Lactate Sodium Chloride Magnesium Chloride Hexahydrate
Calcium Chloride Dihydrate Glucose Monohydrate (Glucose anhydrous)
3.925g 5.786g 0.1017g 0.2573g 42.5g
|
Peritoneal Dialysis Solution
|
Peritoneal Dialysis Solution
|
Fresenius Medical Care Production SDN. BHD.
|
Malaysia
|
Initial (Rx)(Correction)
|
07 August 2022
|
18 April 2027
|
| View |
DR-XY47929_PI_01.pdf
|
DR-XY47929
|
Linagliptin + Metformin Hydrochloride
|
Trajenta Duo
|
2.5 mg/1 g
|
Film-Coated Tablet
|
Drugs Used In Diabetes (Combinations Of Oral Blood Glucose Lowering Drugs)
|
|
|
Initial (Variation)
|
10 August 2022
|
12 April 2027
|
| View |
DR-XY47930_PI_01.pdf
|
DR-XY47930
|
Linagliptin + Metformin Hyydrochloride
|
Trajenta Duo
|
2.5mg/850mg
|
Film-Coated Tablet
|
Oral Blood Glucose Lowering Drug Combination
|
Boehringer Ingelheim Promeco, S.A. de C.V.
|
Mexico
|
Initial
|
12 April 2022
|
12 April 2027
|