| View |
DR-XY48388_PI_01.pdf
|
DR-XY48388
|
Gemigliptin (as tartrate sesquihydrate) + Metformin
hydrochloride
|
Zemimet SR
|
50mg/1 g
|
Film-Coated Tablet
|
Oral Blood Glucose Lowering Drug Combination
|
LG Chem, Ltd.
|
Korea
|
Monitored Release
|
04 October 2022
|
04 October 2025
|
| View |
|
DR-XY48389
|
Levofloxacin (as hemihydrate) + Dexamethasone (as
sodium phosphate)
|
Ducressa
|
5 mg / 1 mg per mL
|
Ophthalmic Solution (Eye Drops)
|
Anti-infective-Anti-inflammatory Combination
|
Tubilux Pharma S.p.A.
|
Italy
|
Monitored Release
|
03 October 2022
|
03 October 2027
|
| View |
|
DR-XY48390
|
Lurasidone Hydrochloride
|
Lurasitor 40
|
40 mg
|
Film-Coated Tablet
|
Antipsychotic (Indole Derivative)
|
Torrent Pharmaceuticals Ltd.
|
India
|
Monitored Release
|
03 October 2022
|
03 October 2025
|
| View |
|
DR-XY48391
|
Amlodipine (as besilate)
|
Eodine 10
|
10 mg
|
Tablet
|
-
|
Ciron Drugs & Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
05 October 2022
|
05 October 2027
|
| View |
|
DR-XY48392
|
Amlodipine (as besilate)
|
Eodine 5
|
5 mg
|
Tablet
|
-
|
Ciron Drugs & Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
05 October 2022
|
05 October 2027
|
| View |
|
DR-XY48393
|
Oxycodone Hydrochloride
|
Oxynorm
|
50mg/mL
|
Solution For Injection Or Infusion (SC/IV)
|
Opioid Analgesic
|
Rafa Laboratories Ltd.
|
Israel
|
Monitored Release
|
04 October 2022
|
04 October 2027
|
| View |
|
DR-XY48394
|
Colecalciferol (Vitamin D3)
|
None
|
1000 IU
|
Softgel Capsule
|
Vitamin
|
Northfield Laboratories Inc.
|
Philippines
|
Initial (OTC)
|
04 October 2022
|
04 October 2027
|
| View |
|
DR-XY48395
|
Colecalciferol (Vitamin D3)
|
None
|
3000 IU
|
Softgel Capsule
|
Vitamin
|
Northfield Laboratories Inc.
|
Philippines
|
Initial (OTC)
|
04 October 2022
|
04 October 2027
|
| View |
|
DR-XY48396
|
Colecalciferol (Vitamin D3)
|
None
|
5000 IU
|
Softgel Capsule
|
-
|
Northfield Laboratories Inc.
|
Philippines
|
Initial (OTC)
|
04 October 2022
|
04 October 2027
|
| View |
|
DR-XY48397
|
Colecalciferol (Vitamin D3)
|
Soli-D
|
4000 IU
|
Chewable Tablet
|
Vitamin
|
Uždaroji Akcinė Bendrovė "Aconitum"
|
Lithuania
|
Initial (OTC) Correction
|
25 November 2022
|
05 October 2027
|
| View |
|
DR-XY48398
|
Tranexamic Acid
|
Actranex
|
500 mg/5 mL (100 mg/mL)
|
Solution for Injection
|
Anti-fibrinolytic
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
04 October 2022
|
04 October 2027
|
| View |
DR-XY48399_PI_01.pdf
|
DR-XY48399
|
Exemestane
|
Brestane
|
25mg
|
Film-Coated Tablet
|
Aromatase Inhibitor
|
Synthon Hispania S.L.
|
Spain
|
Initial (Reapplication)
|
05 October 2022
|
05 October 2027
|
| View |
DR-XY48400_PI_01.pdf
|
DR-XY48400
|
Indacaterol (as acetate) + Mometasone furoate
|
Atectura Breezhaler
|
150 mcg/ 320 mcg (equivalent to 125 mcg/ 260 mcg
delivered dose)
|
Powder for Inhalation in Hard Capsule
|
Adrenergic-Corticosteroid Combination
|
Novartis Pharma Stein AG
|
Switzerland
|
Monitored Release
|
07 October 2022
|
07 October 2027
|
| View |
|
DR-XY48401
|
Indacaterol (as acetate) + Mometasone furoate
|
Atectura Breezhaler
|
150 mcg/ 160 mcg (equivalent to 125 mcg/ 127.5 mcg
delivered dose)
|
Powder for Inhalation in Hard Capsule
|
Adrenergic-Corticosteroid Combination
|
Novartis Pharma Stein AG
|
Switzerland
|
Monitored Release
|
07 October 2022
|
07 October 2027
|
| View |
DR-XY48402_PI_01.pdf
|
DR-XY48402
|
Indacaterol (as acetate) + Mometasone furoate
|
Atectura Breezhaler
|
150 mcg/ 80 mcg (equivalent to 125 mcg/ 62.5 mcg
delivered dose)
|
Powder for Inhalation in Hard Capsule
|
-
|
Novartis Pharma Stein AG
|
Switzerland
|
Monitored Release
|
07 October 2022
|
07 October 2027
|
| View |
|
DR-XY48403
|
Indacaterol (as acetate) + Mometasone furoate
|
None
|
150 mcg/ 320 mcg (equivalent to 125 mcg/ 260 mcg delivered dose)
|
Powder for Inhalation in Hard Capsule
|
Adrenergic-Corticosteroid Combination
|
Novartis Pharma Stein AG
|
Switzerland
|
Monitored Release
|
07 October 2022
|
07 October 2027
|
| View |
|
DR-XY48404
|
Indacaterol (as acetate) + Mometasone furoate
|
None
|
150 mcg/ 160 mcg (equivalent to 125 mcg/ 127.5 mcg delivered dose)
|
Powder for Inhalation in Hard Capsule
|
Adrenergic-Corticosteroid Combination
|
Novartis Pharma Stein AG
|
Switzerland
|
Monitored Release
|
07 October 2022
|
07 October 2027
|
| View |
|
DR-XY48405
|
Indacaterol (as acetate) + Mometasone furoate
|
None
|
150 mcg/ 80 mcg (equivalent to 125 mcg/ 62.5 mcg delivered dose)
|
Powder for Inhalation in Hard Capsule
|
Adrenergic-Corticosteroid Combination
|
Novartis Pharma Stein AG
|
Switzerland
|
Monitored Release
|
07 October 2022
|
07 October 2027
|
| View |
|
DR-XY48406
|
Lurasidone Hydrochloride
|
Lurasitor 80
|
80 mg
|
Film-Coated Tablet
|
-
|
Torrent Pharmaceuticals Ltd.
|
India
|
Monitored Release
|
06 October 2022
|
06 October 2025
|
| View |
DR-XY48407_PI_01.pdf
|
DR-XY48407
|
Indacaterol Acetate + Glycopyrronium Bromide + Mometasone Furoate
|
Enerzair Breezhaler
|
150mcg/50mcg/80mcg
|
Powder for inhalation in Hard capsules
|
Selective Beta-2 adrenoreceptor Agonist/
Anticholinergic/ Corticosteroid
|
Novartis Pharma Stein AG
|
Switzerland
|
Monitored Release
|
07 October 2022
|
07 October 2025
|