| View |
DR-XY48267_PI_01.pdf
|
DR-XY48267
|
Darunavir
|
Danavir 400
|
400mg
|
Film Coated Tablet
|
Antiviral (Protease Inhibitor)
|
Hetero Labs Limited (Unit III)
|
India
|
Monitored Release
|
10 August 2022
|
10 August 2025
|
| View |
DR-XY48268_PI_01.pdf
|
DR-XY48268
|
Darunavir
|
Danavir 600
|
600mg
|
Film Coated Tablet
|
Antiviral (Protease Inhibitor)
|
Hetero Labs Limited (Unit III)
|
India
|
Monitored Release
|
10 August 2022
|
10 August 2025
|
| View |
|
DR-XY48269
|
Ropinirole (as hydrochloride)
|
Kinetica
|
4 mg
|
Prolonged Release Tablet
|
Anti-Parkinson Drug (Dopamine Agonist)
|
KRKA, d.d., Novo Mesto
|
Slovenia
|
Initial
|
10 August 2022
|
10 August 2027
|
| View |
|
DR-XY48270
|
Atorvastatin (as calcium) + Ezetimibe
|
Atorzet 20
|
40 mg / 10 mg
|
Film-Coated Tablet
|
HMG COA Reductase Inhibitor/ Lipid Modifying Agent
|
Medisure Laboratories Pakistan (Pvt.) Ltd.
|
Pakistan
|
Monitored Release
|
10 August 2022
|
10 August 2027
|
| View |
|
DR-XY48271
|
Mesalazine
|
Misal
|
1 g
|
Suppository
|
Intestinal Anti-inflammatory Agent
|
Kusum Healthcare Pvt. Ltd.
|
India
|
Monitored Release
|
10 August 2022
|
10 August 2027
|
| View |
|
DR-XY48272
|
Lenalidomide
|
Linadex 5
|
5mg
|
Capsule
|
-
|
Hetero Labs Limited (Unit-V, Block-VB)
|
India
|
Monitored Release
|
10 August 2022
|
10 August 2025
|
| View |
|
DR-XY48273
|
Oxaliplatin
|
Platixel
|
5mg/mL
|
Concentrate for Solution For I.V. Infusion
|
Antineoplastic Agent
|
Sichuan Huiyu Pharmaceutical Company Limited
|
China
|
Initial
|
15 August 2022
|
15 August 2027
|
| View |
|
DR-XY48274
|
Docetaxel
|
Docebil
|
80 mg/ 2 mL
|
Concentrate for Solution for (IV) Infusion
|
Antineoplastic
|
SP Accure Labs Pvt. Ltd.
|
India
|
Initial
|
12 August 2022
|
12 August 2027
|
| View |
|
DR-XY48275
|
Docetaxel
|
Hexcet
|
80 mg/2 mL
|
Concentrate for Solution for IV Infusion
|
Antineoplastic
|
SP Accure Labs Pvt. Ltd.
|
India
|
Initial
|
11 August 2022
|
11 August 2027
|
| View |
DR-XY48276_PI_01.pdf
|
DR-XY48276
|
Fimasartan potassium + Amlodipine (as besilate)
|
Dukarb
|
60 mg/10 mg
|
Film-Coated Tablet
|
-
|
Boryung Pharmaceutical Co., ltd.
|
Korea
|
Monitored Release
|
11 August 2022
|
11 August 2025
|
| View |
|
DR-XY48277
|
Myox
|
Etoricoxib
|
120 mg
|
Film-Coated Tablet
|
-
|
Cadila Pharmaceuticals Limited
|
India
|
Initial
|
11 August 2022
|
11 August 2027
|
| View |
|
DR-XY48278
|
Erdosteine
|
Vostrin
|
300mg
|
Capsule
|
Mucolytic
|
PT. Novell Pharmaceutical Laboratories
|
Indonesia
|
Initial
|
11 August 2022
|
11 August 2027
|
| View |
|
DR-XY48279
|
Lactulose
|
Lactusol
|
3.35g/5mL
|
Oral Solution
|
Osmotically Acting Laxative
|
KCK Pharmaceutical Industries Sdn. Bhd.
|
Malaysia
|
Initial
|
12 August 2022
|
12 August 2027
|
| View |
|
DR-XY48280
|
Solifenacin Succinate
|
Abo 5
|
5 mg
|
Film-Coated Tablet
|
-
|
Unison Laboratories Co., Ltd.
|
Thailand
|
Initial
|
15 August 2022
|
15 August 2027
|
| View |
|
DR-XY48282
|
Oseltamivir (as phosphate)
|
Oselvir
|
75mg
|
Capsule
|
Antiviral (Neuraminidase inhibitor)
|
The Government Pharmaceutical Organization
|
Thailand
|
Initial (Correction)
|
26 January 2023
|
15 August 2027
|
| View |
DR-XY48283_PI_01.pdf
|
DR-XY48283
|
Dolutegravir (as sodium)
|
None
|
50 mg
|
Film-Coated Tablet
|
Direct Acting Antiviral
|
Mylan Laboratories Limited
|
India
|
Monitored Release (Reconstruction)
|
24 January 2023
|
15 August 2027
|
| View |
DR-XY48284_PI_01.pdf
|
DR-XY48284
|
Lamivudine + Tenofovir disoproxil Fumarate + Dolutegravir (as sodium)
|
Acriptega
|
300 mg/300 mg/50 mg
|
Film-Coated Tablet
|
Direct Acting Antiviral
|
Mylan Laboratories Limited
|
India
|
Monitored Release
|
07 March 2023
|
15 August 2027
|
| View |
DR-XY48285_PI_01.pdf
|
DR-XY48285
|
Dolutegravir (as sodium) + Emtricitabine + Tenofovir
alafenamide (as fumarate)
|
Kocitaf
|
50 mg/200 mg/25 mg
|
Film-Coated Tablet
|
Direct Acting Antiviral
|
Mylan Laboratories Limited
|
India
|
Monitored Release (Reconstruction)
|
07 March 2023
|
15 August 2027
|
| View |
|
DR-XY48286
|
Haloperidol Decanoate
|
Seredol Deca
|
50mg/mL
|
Solution for Injection (IM)
|
Antipsychotic
|
Atlantic Laboratories Corp., Ltd.
|
Thailand
|
Initial [Rx]
|
16 August 2022
|
16 August 2027
|
| View |
|
DR-XY48287
|
Fenofibric Acid
|
None
|
35 mg
|
Softgel Capsule
|
Lipid Modifying Agent
|
Amherst Laboratories, Inc.
|
Philippines
|
Monitored Release (Re-application)
|
15 August 2022
|
15 August 2027
|