| View |
|
DR-XY49047
|
Varenicline (as tartrate)
|
Champix
|
1 mg
|
Film-Coated Tablet
|
Drugs used in nicotine dependence
|
Pfizer Italia S.r.1.
|
Italy
|
Initial
|
19 April 2024
|
19 April 2029
|
| View |
|
DR-XY49048
|
Varenicline (as tartrate)
|
Champix
|
500 mcg
|
Film-Coated Tablet
|
Drugs used in nicotine dependence
|
Pfizer Italia S.r.1.
|
Italy
|
Initial
|
19 April 2024
|
19 April 2029
|
| View |
|
DR-XY49049
|
Sterile Water for Irrigation.
|
Klean & Kare
|
None
|
None
|
None
|
A.N.B. Laboratories Co., Ltd.
|
Thailand
|
Initial
|
17 April 2024
|
17 April 2029
|
| View |
|
DR-XY49050
|
Pantoprazole (as sodium)
|
Panzel
|
40 mg
|
Enteric-Coated Tablet
|
Proton Pump Inhibitor
|
Zee Laboratories.
|
India
|
Initial
|
17 April 2024
|
17 April 2029
|
| View |
|
DR-XY49051
|
Ticagrelor
|
Tigemac 90
|
90 mg
|
Film-Coated Tablet
|
Platelet Aggregation Inhibitor Excl. Heparin
|
Macleods Pharmaceuticals Limited
|
India
|
Initial
|
17 April 2024
|
17 April 2029
|
| View |
|
DR-XY49052
|
Lisinopril (as dihydrate)
|
Zestril
|
5 mg
|
Tablet
|
Angiotensin-Converting Enzyme (ACE) Inhibitor
|
Rovi Pharma Industrial Services, S.A.
|
Spain
|
Initial
|
17 April 2024
|
17 April 2029
|
| View |
|
DR-XY49053
|
Lisinopril (as dihydrate)
|
Zestril
|
10 mg
|
Tablet
|
Angiotensin-Converting Enzyme (ACE) Inhibitor
|
Rovi Pharma Industrial Services, S.A.
|
Spain
|
Initial
|
17 April 2024
|
17 April 2029
|
| View |
|
DR-XY49054
|
Lisinopril (as dihydrate)
|
Zestril
|
20 mg
|
Tablet
|
Angiotensin-Converting Enzyme (ACE) Inhibitor
|
Rovi Pharma Industrial Services, S.A.
|
Spain
|
Initial
|
17 April 2024
|
17 April 2029
|
| View |
|
DR-XY49055
|
Amlodipine (as besilate) + Olmesartan medoxomil
|
Olmesar-AM 10/40
|
10 mg/40 mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker and Calcium Channel
Blocker
|
Hetero Labs Limited (Unit V)
|
India
|
Initial
|
17 April 2024
|
17 April 2029
|
| View |
|
DR-XY49056
|
Gliclazide
|
Glynoprex MR
|
60 mg
|
Modified Release Tablet
|
Blood Glucose Lowering Drug (Sulfonylurea)
|
The ACME Laboratories Limited
|
Bangladesh
|
Initial
|
18 April 2024
|
18 April 2029
|
| View |
|
DR-XY49057
|
Moxifloxacin (as hydrochloride)
|
Demoxif
|
400 mg
|
Film-Coated Tablet
|
Antibacterial (Fluoroquinolone)
|
Deva Holding A.S.
|
Turkey
|
Initial (Re-application)
|
19 April 2024
|
19 April 2029
|
| View |
|
DR-XY49058
|
Pregabalin
|
Prenaxon
|
75 mg
|
Capsule
|
Gabapentinoid
|
Steril-Gene Life Sciences (P) Limited.
|
India
|
Initial (Correction).
|
30 July 2024
|
23 April 2026
|
| View |
|
DR-XY49059
|
Pregabalin
|
Prenaxon
|
150 mg
|
Capsule
|
Gabapentinoid
|
Sterile-Gene Life Sciences (P) Ltd.
|
India
|
Initial
|
23 April 2024
|
23 April 2026
|
| View |
|
DR-XY49060
|
Milrinone (as lactate)
|
Milronex
|
1 mg/mL (10 mg/10 mL)
|
Solution for Injection (IV)
|
Phosphodiesterase Inhibitor
|
United Biotech Pvt. Ltd.
|
India
|
Monitored Release
|
29 April 2024
|
29 April 2029
|
| View |
|
DR-XY49061
|
Norepinephrine
|
Norepors
|
1 mg/mL
|
Concentrated Solution for I.V. Injection
|
Adrenergic/Dopaminergic Agent
|
Med Biopharma Pvt. Ltd.
|
India
|
Initial Correction]
|
28 May 2024
|
29 April 2029
|
| View |
|
DR-XY49062
|
Valproic Acid
|
Valprex
|
250 mg/5 mL
|
Syrup
|
Antiepileptic (Fatty Acid Derivative)
|
Mercury Laboratories Ltd.
|
India
|
Initial
|
30 April 2024
|
30 April 2029
|
| View |
|
DR-XY49063
|
Tadalafil
|
Tadamate 5
|
5 mg
|
Film-Coated Tablet
|
Drug Used in Erectile Dysfunction
|
Intas Pharmaceuticals Limited
|
India
|
Initial
|
30 April 2024
|
30 April 2029
|
| View |
|
DR-XY49064
|
Tadalafil
|
Tadamate 20
|
20 mg
|
Film-Coated Tablet
|
Drug Used in Erectile Dysfunction.
|
Intas Pharmaceuticals Limited
|
India
|
Initial
|
30 April 2024
|
30 April 2029
|
| View |
|
DR-XY49065
|
Sitagliptin (as hydrochloride monohydrate)
|
Diasit 100
|
100 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-XY49066
|
Sitagliptin (as hydrochloride monohydrate)
|
Diasit 50
|
50 mg
|
Film Coated Tablet
|
Dipeptidyl Peptidase 4 (DPP-4) Inhibitor
|
Aurobindo Pharma Limited, Formulation Unit - XV
|
India
|
Initial
|
02 May 2024
|
02 May 2029
|