| View |
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DR-XY48670
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Lenalidomide
|
Lenalid 10
|
10 mg
|
Capsule
|
-
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Natco Pharma Limited (Unit IV and V)
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Monitored Release (MR)
|
28 March 2023
|
28 March 2027
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| View |
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DR-XY48671
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Lenalidomide
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Lenalid 5
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5 mg
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Capsule
|
-
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Natco Pharma Limited (Unit IV and V)
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India
|
Monitored Release (MR)
|
28 March 2023
|
28 March 2027
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| View |
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DR-XY48672
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Multivitamins + Minerals
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Berocca Energy
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Formulation
Each Effervescent Tablet:
Ascorbic acid (Vitamin C) 500 mg
Calcium (as calcium carbonate and calcium pantothenate) 100 mg
Magnesium (as magnesium carbonate and magnesium sulfate dihydrate) 100 mg
Nicotinamide (Vit B3) 50 mg
Panthothenic Acid (Vit B5) 23 mg
Thiamine hydrochloride (Vit B1) 15 mg
Riboflavin (Vit B2) 15 mg
Pyridoxine hydrochloride (Vit B6) 10 mg
Folic acid (Pteroylmonoglutamic acid) 10 mg
Zinc (as zinc citrate trihydrate)400 mcg Biotin (Vit H) 150 mcg
Cyanocobalamin (Vit B12) 10 mcg
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Effervescent Tablet
(Mango Flavour)
|
-
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PT. Bayer Indonesia
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Initial (OTC)
|
29 March 2023
|
29 March 2028
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| View |
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DR-XY48673
|
Multivitamins + Minerals
|
Berocca Energy
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Formulation
Each Effervescent Tablet:
Ascorbic acid (Vitamin C) 500 mg
Calcium (as calcium carbonate and calcium pantothenate) 100 mg
Magnesium (as magnesium carbonate and magnesium sulfate dihydrate) 100 mg
Nicotinamide (Vit B3) 50 mg
Panthothenic Acid (Vit B5) 23 mg
Thiamine hydrochloride (Vit B1) 15 mg
Riboflavin (Vit B2) 15 mg
Pyridoxine hydrochloride (Vit B6) 10 mg
Zinc (as zinc citrate trihydrate) 10 mg
Folic acid (Pteroylmonoglutamic acid) 400 mcg Biotin (Vit H) 150 mcg
Cyanocobalamin (Vit B12) 10 mcg
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Effervescent Tablet (Orange Flavour)
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Vitamins/Minerals
|
PT. Bayer Indonesia
|
Indonesia
|
Initial (OTC)
|
29 March 2023
|
29 March 2028
|
| View |
DR-XY48674_PI_01.pdf
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DR-XY48674
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Ibrutinib
|
Imbruvica
|
420 mg
|
Film-Coated Tablet
|
Antineoplastic Agent (Protein Kinase Inhibitor)
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Cilag AG
|
Switzerland
|
Monitored Release (Correction)
|
28 September 2023
|
30 March 2028
|
| View |
DR-XY48675_PI_01.pdf
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DR-XY48675
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Ibrutinib
|
Imbruvica
|
140 mg
|
Film-Coated Tablet
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Antineoplastic Agent (Protein Kinase Inhibitor)
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Cilag AG
|
Switzerland
|
Monitored Release (Correction)
|
28 September 2023
|
30 March 2028
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| View |
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DR-XY48676
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Rivaroxaban
|
Varoxan
|
20 mg
|
Film-Coated Tablet
|
-
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Lloyd Laboratories, Inc.
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|
Initial
|
29 March 2023
|
29 March 2028
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| View |
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DR-XY48677
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Rivaroxaban
|
Varoxan
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15 mg
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Film-Coated Tablet
|
-
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Lloyd Laboratories, Inc.
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Initial
|
29 March 2023
|
29 March 2028
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| View |
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DR-XY48678
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Icatibant
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Firazyr
|
10 mg/mL (30 mg/3 mL)
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Solution For Injection (SC)
|
-
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Vetter Pharma-Fertigung GmbH & Co. KG
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Monitored Release
|
29 March 2023
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29 March 2028
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| View |
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DR-XY48679
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Peritoneal Dialysis Solution with 2.3% Dextrose
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CAPD/DPCA 19 Stay Safe Link
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Formulation:
Each L of Solution contains:
Glucose (Dextrose) -22.73 g
equivalent to 25 g glucose monohydrate
Sodium Chloride -5.786 g
Sodium Lactate -3.925 g
Calcium chloride dihydrate -0.1838 g
Magnesium chloride hexahydrate-0.1017 g
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Peritoneal Dialysis Solution
|
-
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Fresenius Medical Care Production Sdn. Bhd.
|
|
Initial
|
29 March 2023
|
29 March 2028
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| View |
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DR-XY48680
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Mycophenolate Mofetil
|
Mycept
|
250 mg
|
Capsule
|
-
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Panacea Biotec Ltd.
|
India
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Initial (Reconstruction)
|
03 August 2023
|
29 March 2028
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| View |
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DR-XY48681
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Tadalafil
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None
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20 mg
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Orodispersible Film
|
-
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Zim Laboratories Limited
|
India
|
Monitored Release
|
30 March 2023
|
30 March 2028
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| View |
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DR-XY48682
|
Tadalafil
|
None
|
10 mg
|
Orodispersible Film
|
-
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Zim Laboratories Limited
|
India
|
Monitored Release
|
30 March 2023
|
30 March 2028
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| View |
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DR-XY48683
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Tadalafil
|
Thafil 10
|
10mg
|
Orodispersible Film
|
-
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Zim Laboratories Limited
|
India
|
Monitored Release
|
30 March 2023
|
30 March 2028
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| View |
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DR-XY48684
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Candesartan cilexetil
|
Torcand-32
|
32 mg
|
Tablet
|
-
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Torrent Pharmaceuticals Ltd.
|
India
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Monitored Release (MR) (Correction)
|
02 August 2023
|
31 March 2028
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| View |
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DR-XY48686
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Oxaliplatin
|
Rexta
|
5 mg/mL (100 mg/20 mL)
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Concentrate Solution for I.V.
Infusion
|
-
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PT. Global Onkolab Farma
|
Indonesia
|
Initial
|
31 March 2023
|
31 March 2025
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| View |
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DR-XY48687
|
Oxaliplatin
|
Rexta
|
5 mg/mL (50 mg/10 mL)
|
Concentrate Solution for I.V.
Infusion
|
-
|
PT. Global Onkolab Farma
|
Indonesia
|
Initial
|
31 March 2023
|
31 March 2025
|
| View |
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DR-XY48688
|
Acetated Ringer's Solution
|
None
|
Formulation:
Each 100 mL contains:
Sodium chloride 600 mg
Sodium acetate trihydrate 380 mg
Potassium chloride 30 mg
Calcium chloride dihydrate 20 mg
|
Solution for I.V. Infusion
|
-
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A.N.B. Laboratories Co., Ltd.
|
Thailand
|
Initial
|
03 April 2023
|
03 April 2028
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| View |
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DR-XY48689
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Rivaroxaban
|
Ixobran 10
|
10 mg
|
Film-Coated Tablet
|
-
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Inventia Healthcare Limited
|
India
|
Initial
|
03 April 2023
|
03 April 2028
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| View |
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DR-XY48690
|
Thymalfasin
|
Heri
|
1.6 mg
|
Lyophilized Powder for Injection (SC)
|
-
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Hainan Zhonghe Pharmaceutical Co., Ltd.
|
China
|
Monitored Release
|
04 April 2023
|
04 April 2028
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