| View |
DR-XY48815_PI_01.pdf
|
DR-XY48815
|
Irbesartan
|
Bezartan
|
300mg
|
Film-Coated Tablet
|
-
|
Duopharma Manufacturing (Bangi) Sdn. Bhd.
|
Malaysia
|
Initial (Re-application)
|
18 July 2023
|
18 July 2028
|
| View |
|
DR-XY48816
|
Sodium Hyaluronate
|
Optanate
|
1mg/mL (0.1%)
|
Ophthalmic Solution (Eye Drops)
|
-
|
Daewoo Pharm. Co., Ltd.
|
Korea
|
Initial (Reapplication)
|
18 July 2023
|
18 July 2028
|
| View |
|
DR-XY48817
|
Zoledronic Acid (as monohydrate)
|
Sinresor
|
4 mg
|
Lyophilized Powder For Iv Infusion
|
-
|
Laboratorio Kemex S.A.
|
Argentina
|
Initial (Reapplication)
|
18 July 2023
|
18 July 2028
|
| View |
DR-XY48818_PI_01.pdf
|
DR-XY48818
|
Levonorgestrel
|
Jadelle
|
75mg
|
Implant (For Subdermal Use Only)
|
-
|
Bayer Oy
|
Finland
|
Monitored Release (MR) (Re-application)
|
31 July 2023
|
21 July 2028
|
| View |
|
DR-XY48819
|
Cholecalciferol (Vitamin D3)
|
Cholevit
|
1000 IU
|
Softgel Capsule
|
-
|
Phil Inter Pharma Co., Ltd. (Plant 1)
|
Vietnam
|
Initial [OTC]
|
21 July 2023
|
21 July 2028
|
| View |
DR-XY48820_PI_01.pdf
|
DR-XY48820
|
Lurasidone Hydrochloride
|
Latuda
|
20 mg
|
Film-Coated Tablet
|
-
|
Bushu Pharmaceuticals Ltd. (Kawagoe Factory)
|
Japan
|
Monitored Release
|
25 July 2023
|
25 July 2028
|
| View |
|
DR-XY48821
|
Gabapentin
|
Unogaba 400
|
400 mg
|
Capsule
|
Gabapentinoid
|
Steril-Gene Life Sciences (P) Limited
|
India
|
Initial (Correction)
|
29 May 2024
|
27 July 2028
|
| View |
|
DR-XY48822
|
Linagliptin
|
Lynorm
|
5 mg
|
Film-Coated Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
27 July 2023
|
27 July 2028
|
| View |
|
DR-XY48823
|
Digoxin
|
Lanoxin
|
250 mcg
|
Tablet
|
-
|
Aspen Bad Oldesloe GmbH
|
Germany
|
Initial
|
28 July 2023
|
28 July 2028
|
| View |
|
DR-XY48824
|
Paracetamol + Guaifenesin + Phenylpropanolamine
(as hydrochloride) + Dextromethorphan hydrobromide + Chlorpheniramine maleate
|
Dexofen
|
325 mg/50 mg/10 mg/10 mg/2 mg
|
Capsule
|
-
|
Drugmaker's Laboratories, Inc.
|
Philippines
|
Initial
|
31 July 2023
|
31 July 2028
|
| View |
|
DR-XY48825
|
Etoricoxib
|
Forsanec 120
|
120 mg
|
Tablet
|
-
|
Kusum Healthcare Pvt. Ltd.
|
India
|
Initial (Re-application)
|
28 July 2023
|
28 July 2028
|
| View |
|
DR-XY48826
|
Ampicillin (as sodium) + Sulbactam (as sodium)
|
Dypisul 750
|
500mg/250mg
|
Powder For Injection (IM/IV)
|
-
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial (Re-application)
|
28 July 2023
|
28 July 2028
|
| View |
|
DR-XY48827
|
Ampicillin (as sodium) + Sulbactam (as sodium)
|
Dypisul 1.5
|
1G/500mg
|
Powder for Injection (I.M./I.V.)
|
-
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial (Re-application)
|
28 July 2023
|
28 July 2028
|
| View |
|
DR-XY48828
|
Linezolid
|
Zoldap
|
600mg
|
Film-Coated Tablet
|
-
|
Getz Pharma Pvt. Ltd.
|
Pakistan
|
Initial
|
02 August 2023
|
02 August 2028
|
| View |
|
DR-XY48829
|
Ivabradine (as hydrochloride)
|
Ibracor
|
5 mg
|
Film-Coated Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
01 August 2023
|
01 August 2028
|
| View |
|
DR-XY4883
|
Amlodipine (as Besilate) + Olmesartan Medoxomil
|
Olmesar-Am 5/40
|
5 mg/40 mg
|
Film-Coated Tablet
|
-
|
Hetero Labs Limited (Unit V)
|
India
|
Initial
|
01 August 2023
|
01 August 2028
|
| View |
|
DR-XY48830
|
Dapagliflozin
|
Forzinorm
|
10 mg
|
Film-Coated Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
02 August 2023
|
02 August 2028
|
| View |
|
DR-XY48831
|
Clotimazole
|
Candigo
|
10mg/g (1% w/w)
|
Cream
|
-
|
Kusum Healthcare Pvt. Ltd.
|
India
|
Initial (Correction)
|
01 August 2023
|
06 June 2028
|
| View |
|
DR-XY48832
|
Amlodipine (as Besilate + Olmesartan Medoxomil
|
Olmesar-Am 5/20
|
5 mg/20 mg
|
Tablet
|
-
|
Hetero Labs Limited (Unit V)
|
India
|
Initial
|
01 August 2023
|
01 August 2028
|
| View |
DR-XY48834_PI_01.pdf
|
DR-XY48834
|
Cabotegravir
|
Apretude
|
200 mg/mL (600 mg/3 mL)
|
Prolonged-Release
Suspension for Intramuscular Injection (Gluteal)
|
-
|
Glaxo Operations UK Limited
|
United Kingdom
|
Monitored Release
|
03 August 2023
|
03 August 2028
|