| View |
|
DR-XY48076
|
Montelukast (as sodium) + Levocetirizine hydrochloride
|
Molev
|
10 mg/ 5 mg
|
Film Coated Tablet
|
Leukotriene Receptor Antagonist
|
Cadila Healthcare Limited
|
India
|
Initial
|
01 June 2022
|
01 June 2027
|
| View |
|
DR-XY48077
|
Dexketoprofen (as trometamol)
|
Voxib
|
25 mg/ml
|
Solution for Injection (1. M./1.V.) or
Concentrate for Solution for I. V. Infusion
|
Non-steroidal
Anti-inflammatory/Antirheumatic (Propionic Acid Derivative)
|
PT. Novell Pharmaceutical Laboratories
|
Indonesia
|
Initial
|
01 June 2022
|
01 June 2027
|
| View |
DR-XY48078_PI_01.pdf
|
DR-XY48078
|
Azacitidine
|
Azacytin
|
100 mg
|
Lyophilized Powder For Injection (I.V/S.C)
|
-
|
Dr. Reddy's Laboratories Ltd.
|
India
|
Monitored Release
|
01 June 2022
|
01 June 2025
|
| View |
|
DR-XY48079
|
Solifenacin succinate
|
Abo 10
|
10 mg
|
Film-Coated Tablet
|
-
|
Unison Laboratories Co., Ltd.
|
Thailand
|
Initial
|
01 June 2022
|
01 June 2027
|
| View |
|
DR-XY48080
|
Hydroxychloroquine Sulfate
|
HCQS
|
200 mg
|
Film-Coated Tablet
|
Antimalarial/Antirheumatic
|
Ipca Laboratories Limited
|
India
|
Initial
|
02 June 2022
|
02 June 2027
|
| View |
|
DR-XY48081
|
Ceftriaxone (As Sodium)
|
None
|
1 g
|
Powder For Injection (IM/IV)
|
-
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
02 June 2022
|
02 June 2027
|
| View |
|
DR-XY48082
|
Pramipexole dihydrochloride monohydrate
|
Piritan
|
1 mg
|
Tablet
|
Antiparkinson drug (Dopamine Agonist)
|
Kusum Healthcare Pvt. Ltd.
|
India
|
Initial [Correction]
|
08 April 2024
|
06 June 2027
|
| View |
|
DR-XY48083
|
Pramipexole dihydrochloride monohydrate
|
Piritan
|
250 mcg
|
Tablet
|
Antiparkinson drug (Dopamine Agonist)
|
Kusum Healthcare Pvt. Ltd.
|
India
|
Initial [Correction]
|
08 April 2024
|
06 June 2027
|
| View |
|
DR-XY48084
|
Calcium + Colecalciferol (Vitamin D3)
|
Caldi Plus
|
500 mg (equivalent to 1250 mg Calcium Carbonate) / 250 IU
|
Chewable Tablet (Orange Flavor)
|
Mineral / Vitamin
|
Pharmatechnica Laboratory, Inc.
|
Philippines
|
Initial [OTC] (Reconstruction)
|
16 January 2024
|
02 June 2027
|
| View |
|
DR-XY48085
|
Bilastine
|
Bilaxten
|
2.5mg/mL
|
Oral Solution
|
-
|
Berlin-Chemie AG
|
Germany
|
Monitored Release
|
02 June 2022
|
02 June 2027
|
| View |
|
DR-XY48086
|
Amlodipine (as besilate)
|
None
|
10 mg
|
Tablet
|
-
|
The Government Pharmaceutical Organization (Production Plant I-GPO Thanyaburi)
|
Thailand
|
Initial
|
03 June 2022
|
03 June 2027
|
| View |
DR-XY48087_PI_01.pdf
|
DR-XY48087
|
Tadalafil
|
Tadafil 10
|
10 mg
|
Film-Coated Tablet
|
Phosphodiesterase Type-5 Inhibitor (Urological)
|
Hetero Labs Limited
|
India
|
Monitored Release (MR)
|
03 June 2022
|
03 June 2027
|
| View |
DR-XY48088_PI_01.pdf
|
DR-XY48088
|
Tadalafil
|
Tadafil 5
|
5 mg
|
Film-Coated Tablet
|
Phosphodiesterase Type-5 Inhibitor (Urological)
|
Hetero Labs Limited
|
India
|
Monitored Release (MR)
|
03 June 2022
|
03 June 2027
|
| View |
|
DR-XY48089
|
Cisatracurium (as besilate)
|
Cistra
|
2 mg/mL (10 mg/5 mL)
|
Solution for Injection (IV)
|
Neuromauscular Blocker
|
Jiangsu Hengrui Medicine Co., Ltd.
|
China
|
Initial
|
03 June 2022
|
03 June 2027
|
| View |
DR-XY48090_PIL-01.pdf
|
DR-XY48090
|
Ascorbic Acid + Zinc + Vitamin D3
|
None
|
500 mg/10 mg (equivalent to 27.45 mg Zinc Sulfate Monohydrate)/1000 IU
|
Capsule
|
Vitamin/Mineral
|
Northfield Laboratories Inc.
|
Philippines
|
Initial (OTC)
|
06 June 2022
|
06 June 2027
|
| View |
DR-XY48091_PI_01.pdf
|
DR-XY48091
|
Neratinib Maleate
|
Nerlynx
|
40 mg
|
Film-Coated Tablet
|
Antineoplastic Agent (Protein Kinase Inhibitor)
|
Excella GmbH & Co. Kg
|
Germany
|
Monitored Release
|
06 June 2022
|
06 June 2027
|
| View |
|
DR-XY48092
|
Lisinopril (as dihydrate)
|
Huanopril
|
10mg
|
Tablet
|
Angiotensin-converting Enzyme (ACE) Inhibitor
|
Zhejiang Huahai Pharmaceutical Co., Ltd.
|
China
|
Initial
|
06 June 2022
|
06 June 2027
|
| View |
|
DR-XY48093
|
Clindamycin (As Phosphate)
|
Tidact
|
10 mg/g
|
Gel
|
Anti-acne
|
Y.S.P Industries (M) SDN. BHD
|
Malaysia
|
Initial (Correction)
|
02 September 2022
|
02 September 2027
|
| View |
|
DR-XY48094
|
Bortezomib
|
Mibzo
|
3.5 mg
|
Lyophilized Powder For Injection
|
Antineoplastic Agent (Proteasome Inhibitor)
|
MSN Laboratories Private Limited
|
India
|
Initial
|
07 June 2022
|
07 June 2027
|
| View |
|
DR-XY48095
|
Peritoneal Dialysis with 1.5% Dextrose
|
None
|
Each 100 mL contains: Dextrose.... 1.5 g Sodium chloride.... 538 mg
Magnesium chloride hexahydrate .... 5.1 mg
Sodium lactate......448 mg Calcium chloride dihydrate....26 mg
|
Dialysis Solution for Intraperitoneal
|
Peritoneal Dialytics
|
Shijiazhuang No. 4 Pharmaceutical Co., Ltd.
|
China
|
Initial
|
08 June 2022
|
08 June 2027
|