| View |
|
DR-XY49067
|
Sitagliptin (as hydrochloride monohydrate)
|
Diasit 25
|
25 mg
|
Film Coated Tablet
|
Dipeptidyl Peptidase 4 (DPP-4) Inhibitor
|
Aurobindo Pharma Limited, Formulation Unit - XV
|
India
|
Initial
|
02 May 2024
|
02 May 2029
|
| View |
|
DR-XY49068
|
Cinacalcet (as hydrochloride)
|
Cinacred 30
|
30 mg
|
Film-Coated Tablet
|
Anti-parathyroid Agent
|
Dr. Reddy's Laboratories Ltd. (FTO-Unit 2)
|
India
|
Monitored Release (MR)
|
03 May 2024
|
03 May 2029
|
| View |
|
DR-XY49069
|
Cinacalcet (as hydrochloride)
|
Cinacred 60
|
60 mg
|
Film-Coated Tablet
|
Anti-parathyroid Agent
|
Dr. Reddy's Laboratories Ltd. (FTO-Unit 2)
|
India
|
Monitored Release (MR)
|
03 May 2024
|
03 May 2029
|
| View |
|
DR-XY49070
|
Cinacalcet (as hydrochloride)
|
Cinacred 90
|
90 mg
|
Film-Coated Tablet
|
Anti-parathyroid Agent
|
Dr. Reddy's Laboratories Ltd. (FTO-Unit 2)
|
India
|
Monitored Release (MR)
|
03 May 2024
|
03 May 2029
|
| View |
|
DR-XY49071
|
Irbesartan
|
Bezartan
|
150 mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker (ARB)
|
Duopharma Manufacturing (Bangi) Sdn. Bhd.
|
Malaysia
|
Initial (Re-application)
|
06 May 2024
|
06 May 2029
|
| View |
|
DR-XY49072
|
Tranexamic Acid.
|
Pause 500
|
500 mg
|
Film-Coated Tablet
|
Antifibrinolytic (Amino Acid)
|
Emcure Pharmaceuticals Ltd.
|
India
|
Initial
|
07 May 2024
|
07 May 2029
|
| View |
|
DR-XY49073
|
Valproic Acid (as Divalproex sodium)
|
Depakote ER
|
1 g
|
Extended Release Tablet
|
Antiepileptic
|
Abbott Laboratorios Do Brasil LTDA
|
Brazil
|
Monitored Release
|
10 May 2024
|
10 May 2029
|
| View |
|
DR-XY49074
|
Omidenepag isopropyl
|
Eybelis-S
|
20 mcg/mL (0.002% w/v)
|
Sterile Ophthalmic Solution
|
Anti-glaucoma Preparation
|
Santen Pharmaceutical Co., Ltd. (Noto Plant)
|
Japan
|
Monitored Release
|
10 May 2024
|
10 May 2029
|
| View |
|
DR-XY49075
|
Ursodeoxycholic Acid
|
Ursoliv 500
|
500 mg
|
Film-Coated Tablet
|
Bile and Liver Therapy (Bile acids and derivative)
|
Mega Lifesciences Public Company Limited
|
Thailand
|
Initial (Correction)
|
31 July 2024
|
19 September 2027
|
| View |
|
DR-XY49076
|
Febuxostat
|
Euricstat
|
40 mg
|
Film-Coated Tablet
|
Antigout
|
The Acme Laboratories Limited
|
Bangladesh
|
Initial
|
10 May 2024
|
10 May 2029
|
| View |
|
DR-XY49077
|
Dienogest
|
Evafact
|
2 mg
|
Tablet
|
Progestogen (Pregnadien derivative)
|
Naari Pharma Private Limited
|
India
|
Initial
|
13 May 2024
|
13 May 2029
|
| View |
|
DR-XY49078
|
Bisoprolol fumarate
|
Bisovell
|
5 mg
|
Film Coated Tablet
|
Beta Blocking Agent
|
PT. Novell Pharmaceutical Laboratories
|
Indonesia
|
Initial
|
13 May 2024
|
13 May 2029
|
| View |
|
DR-XY49079
|
Bosentan (as monohydrate)
|
Bosenpah 125
|
125 mg
|
Film-Coated Tablet
|
Antihypertensive for Pulmonary Arterial Hypertension
|
Unison Laboratories Co., Ltd.
|
Thailand
|
Initial
|
14 May 2024
|
14 May 2029
|
| View |
|
DR-XY49080
|
Febuxostat
|
Febtout 80
|
80 mg
|
Film-Coated Tablet
|
Anti-gout (Preparation Inhibiting Uric Acid Production)
|
Adnova Healthcare Pvt. Ltd.
|
India
|
Initial
|
15 May 2024
|
15 May 2029
|
| View |
|
DR-XY49081
|
Esomeprazole (as sodium)
|
None
|
40 mg
|
Lyophilized Powder for I.V. Injection.
|
Proton pump inhibitor
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
15 May 2024
|
15 May 2029
|
| View |
|
DR-XY49082
|
Lidocaine hydrochloride + Epinephrine.
|
Crysta FD
|
20 mg/10 mcg per mL
|
Solution for Injection (Local
Infiltration)
|
Local Anesthetic
|
Laboratorios Zeyco S.A. De C.V.
|
Mexico
|
Initial
|
14 May 2024
|
14 May 2029
|
| View |
|
DR-XY49083
|
Atogepant
|
Aquipta
|
10 mg
|
Tablet
|
Antimigraine Preparation [Calcitonin Gene-Related
Peptide (CGRP) Antagonist]
|
AbbVie S.r.I.
|
Italy
|
Monitored Release (FRP Abridged Review)
|
16 May 2024
|
16 May 2029
|
| View |
|
DR-XY49084
|
Atogepant
|
Aquipta
|
60 mg
|
Tablet
|
Antimigraine Preparation [Calcitonin Gene-Related
Peptide (CGRP) Antagonist]
|
AbbVie S.r.I.
|
Italy
|
Monitored Release (FRP Abridged Review)
|
16 May 2024
|
16 May 2029
|
| View |
|
DR-XY49085
|
Ceftriaxone (as sodium)
|
Trixophin-W
|
1 g
|
Sterile Powder for Solution for Injection (IM/IV)
|
Third-Generation Cephalosporin
|
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
|
China
|
Initial
|
17 May 2024
|
17 May 2029
|
| View |
|
DR-XY49086
|
Caspofungin (as acetate)
|
Fungitame 70
|
70 mg
|
Lyophilized Powder for Concentrated Solution for
IV Infusion
|
Other Antimycotic for Systemic Use
|
Pharmaten SA
|
Greece
|
Initial
|
20 May 2024
|
20 May 2029
|