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DR-XY48448_PI_01.pdf
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DR-XY48448
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Fexuprazan Hydrochloride
|
Fexuclue
|
40mg
|
Film-Coated Tablet
|
Potassium-competitive acid blocker (P-CAB)
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Daewoong Pharmaceutical Co., Ltd.
|
South Korea
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Monitored Release
|
03 November 2022
|
03 November 2027
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| View |
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DR-XY48449
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Risperidone
|
None
|
2 mg
|
Orodispersible Tablet
|
-
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Kusum Healthcare Pvt. Ltd.
|
India
|
Initial
|
17 November 2022
|
17 November 2027
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| View |
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DR-XY48450
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Risperidone
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None
|
1 mg
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Orodispersible Tablet
|
-
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Kusum Healthcare Pvt. Ltd.
|
india
|
Initial
|
17 November 2022
|
17 November 2027
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| View |
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DR-XY48451
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Metformin Hydrochloride
|
Meforin
|
500mg
|
Tablet
|
-
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Celogen Generics Private Ltd.
|
India
|
Initial
|
07 November 2022
|
07 November 2027
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| View |
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DR-XY48452
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Remimazolam
|
Byfavo
|
50mg
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Lyophilized Powder for Intravenous Infusion
|
-
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Hana Pharmaceutical Co., Ltd.
|
Korea
|
Reapplication
|
04 July 2023
|
04 July 2028
|
| View |
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DR-XY48453
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Paracetamol + Ibuprofen
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Maselax
|
325mg / 200mg
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Capsule
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Antipyretic/Analgesic/Non-Steroidal Anti-inflammatory Drug (NSAID)
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Saga Laboratories
|
India
|
Initial (OTC)
|
04 November 2022
|
04 November 2027
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| View |
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DR-XY48454
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Ascorbic Acid
|
Effi-C
|
1 g
|
Effervescent Tablet
|
-
|
Scitech Specialties Pvt. Ltd.
|
India
|
Initial (OTC)
|
10 November 2022
|
10 November 2027
|
| View |
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DR-XY48455
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Isotretinoin
|
Isonoin 20
|
20mg
|
Softgel Capsule
|
Anti-Acne
|
Gelnova Laboratories (India) Pvt. Ltd.
|
India
|
Initial
|
04 November 2022
|
04 November 2027
|
| View |
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DR-XY48456
|
Isotretinoin
|
Isonoin 10
|
10mg
|
Softgel Capsule
|
-
|
Gelnova Laboratories (India) Pvt. Ltd.
|
Thailand
|
Initial
|
04 November 2022
|
04 November 2027
|
| View |
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DR-XY48457
|
Peritoneal Dialysis Solution (Lactate-G 4.25%)
|
None
|
FORMULATION:
Each 100 mL contains:
Dextrose Anhydrous
4.25 g
Sodium Chloride
538 mg
Sodium Lactate
448 mg
Calcium Chloride
26 mg
Magnesium Chloride
5.1 mg
|
Solution for Intraperitoneal Administration
|
-
|
Shijiazhuang No. 4 Pharmaceutical Co., Ltd.
|
China
|
Initial
|
17 November 2022
|
17 November 2027
|
| View |
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DR-XY48458
|
Methotrexate
|
Metotrek
|
25 mg/mL (500 mg/20 mL)
|
Solution for Injection (IM/IV)
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Antineoplastic Agent (Folic Acid Analogue)
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United Biotech Pvt. Ltd.
|
India
|
Initial
|
08 November 2022
|
08 November 2027
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| View |
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DR-XY48459
|
Norepinephrine (as Bitartrate)
|
Fresenor
|
1mg/mL
|
Concentrate Solution for IV Infusion.
|
-
|
PT. Ethica Industri Farmasi (PT.Ethica)
|
Indonesia
|
Initial
|
11 November 2022
|
11 November 2027
|
| View |
DR-XY48460_PI_01.pdf
|
DR-XY48460
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Emtricitabine + Tenofovir alafenamide (as hemifumarate)
|
Tafnext -Em
|
200 mg/25 mg
|
Tablet
|
Direct Acting Antiviral
|
Annora Pharma Private Limited
|
India
|
Monitored Release (MR)
|
09 November 2022
|
09 November 2027
|
| View |
|
DR-XY48461
|
Lornoxicam
|
Laxico
|
8 mg
|
Film-Coated Tablet
|
-
|
Kusum Healthcare Pvt. Ltd.
|
India
|
Initial
|
14 November 2022
|
14 November 2027
|
| View |
|
DR-XY48462
|
Glutathione
|
Sitiglow
|
600mg
|
Lyophilized Powder for Injection (IM/IV)
|
Antidote
|
Reyoung Pharmaceutical Co. Ltd.
|
China
|
Initial
|
14 November 2022
|
14 November 2027
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| View |
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DR-XY48463
|
Metformin hydrochloride
|
Metfor PR 1000.
|
1 g
|
Prolonged Release Tablet
|
-
|
USV Private Limited
|
India
|
Initial (Correction)
|
13 October 2023
|
14 November 2027
|
| View |
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DR-XY48464
|
5% Dextrose In Water
|
A.N.B. D5W
|
Each 100mL contains: Dextrose 5g
|
Solution For IV Infusion
|
-
|
A.N.B. Laboratories Co., Ltd.
|
Thailand
|
Initial
|
14 November 2022
|
14 November 2027
|
| View |
DR-XY48465_PI_01.pdf
|
DR-XY48465
|
Rosuvastatin (as calcium) + Ezetimibe
|
Zenon
|
10 mg/ 10 mg
|
Film-Coated Tablet
|
-
|
Sanofi Ilac Sanayi Ve Ticaret Anonim Sirketi
|
Turkey
|
Monitored Release (Re-application)
|
14 November 2022
|
14 November 2027
|
| View |
DR-XY48466_PI_01.pdf
|
DR-XY48466
|
Rosuvastatin (as calcium) + Ezetimibe
|
Zenon
|
20 mg/ 10 mg
|
Film-Coated Tablet
|
-
|
Sanofi Ilac Sanayi Ve Ticaret Anonim Sirketi
|
Turkey
|
Monitored Release (Re-application)
|
14 November 2022
|
14 November 2027
|
| View |
|
DR-XY48467
|
Sodium Hyaluronate
|
Go-Opt
|
1.5 mg/mL (0.15%w/v)
|
Ophthalmic Solution (Eye Drops)
|
-
|
World Medicine İlaç Sanayi Ve Ticaret A.Ş.
|
Turkey
|
Monitored Release
|
14 November 2022
|
14 November 2027
|