| View |
|
DR-XY47460
|
Tadalafil
|
None
|
20 mg
|
Film-Coated Tablet
|
-
|
Cadila Pharmaceuticals Limited
|
India
|
-
|
13 October 2021
|
13 October 2026
|
| View |
|
DR-XY47461
|
Bimatoprost
|
None
|
300 mcg/mL (0.03% w/v)
|
Ophthalmic Solution (Eye Drops)
|
Anti-glaucoma/Miotic (Prostaglandin Analogue)
|
Beximco Pharmaceuticals Limited
|
Bangladesh
|
Initial
|
13 October 2021
|
13 October 2026
|
| View |
DR-XY47462_PI_01.pdf
|
DR-XY47462
|
Salmeterol (as xinafoate) + Fluticasone propionate
|
Saltrol
|
25 mcg/125mcg per Actuation Metered Dose
|
Pressurized
Liquid for Inhalation
|
-
|
Getz Pharma Pvt. Ltd.
|
Pakistan
|
-
|
14 October 2021
|
14 October 2026
|
| View |
|
DR-XY47463
|
Tamsulosin hydrochloride
|
Prostam
|
400 mcg
|
Sustained Release Tablet
|
-
|
PT. Novell Pharmaceutical Laboratories
|
Indonesia
|
-
|
14 October 2021
|
04 October 2026
|
| View |
|
DR-XY474630
|
Ascorbic Acid
|
C3 Plus
|
533.40 mg (equivalent to 600 mg Sodium Ascorbate)
|
Capsule
|
-
|
Interchemex Laboratories, Inc.
|
Philippines
|
-
|
28 September 2021
|
28 September 2026
|
| View |
|
DR-XY47464
|
Caspofungin (as acetate)
|
Fungicas
|
50 mg
|
Lyophilized Powder for Concentrate Solution
for IV Infusion
|
-
|
Mylan Laboratories Limited
|
India
|
-
|
15 October 2021
|
15 October 2026
|
| View |
|
DR-XY47465
|
Caspofungin (as acetate)
|
Fungicas
|
70 mg
|
Lyophilized Powder for Concentrate Solution
for IV Infusion
|
-
|
Mylan Laboratories Limited
|
India
|
-
|
15 October 2021
|
15 October 2026
|
| View |
|
DR-XY47466
|
Ascorbic Acid + Zinc
|
Prime C Forte
|
500 mg (equivalent to 562.43 mg Sodium Ascorbate)/10
mg (equivalent to 70 mg Zinc Gluconate)
|
Capsule
|
-
|
J.M. Tolmann Laboratories Inc.
|
Philippines
|
-
|
18 October 2021
|
18 October 2026
|
| View |
|
DR-XY47467
|
Ibuprofen
|
Aceprofen
|
400 mg
|
Film Coated Tablet
|
-
|
Umedica Laboratories PVT. Ltd.
|
India
|
-
|
19 October 2021
|
19 October 2026
|
| View |
|
DR-XY47468
|
Montelukast (as sodium) + Levocetirizine
hydrochloride
|
Montral
|
10mg/ 5mg
|
Film-Coated Tablet
|
Leukotriene Receptor Antagonist-Antihistamine
Combination
|
Micro Labs Limited
|
India
|
Automatic Renewal
|
23 February 2022
|
18 October 2026
|
| View |
|
DR-XY47470
|
Diclofenac
|
Voltaren Emulgel 12 Hours
|
18.6mg/g (1.86% w/w)
|
Topical Gel
|
-
|
GSK Consumer Healthcare S.A.
|
Switzerland
|
-
|
22 October 2021
|
22 October 2026
|
| View |
|
DR-XY47471
|
Rifampicin + Isoniazid + Pyrazinamide
|
None
|
75 mg/50 mg/150 mg
|
Dispersible Tablet
|
-
|
Macleods Pharmaceuticals Limited
|
India
|
Monitored Release (CPR Correction)
|
19 August 2022
|
20 October 2026
|
| View |
|
DR-XY47472
|
Rifampicin + Isoniazid + Pyrazinamide
|
None
|
75 mg/50 mg/150 mg
|
Dispersible Tablet
|
-
|
Macleods Pharmaceutical Ltd.
|
India
|
-
|
20 October 2021
|
20 October 2026
|
| View |
|
DR-XY47473
|
Esomeprazole (as magnesium trihydrate)
|
Esoric 20
|
20 mg
|
Enteric Coated Tablet
|
Proton Pump Inhibitor
|
Mepro Pharmaceuticals Private Limited
|
India
|
-
|
22 December 2021
|
23 December 2026
|
| View |
|
DR-XY47474
|
Esomeprazole (as magnesium trihydrate)
|
Esoric 40
|
40mg
|
Enteric Coated Tablet
|
Proton Pump Inhibitor
|
Mepro Pharmaceuticals Private Limited
|
India
|
Initial
|
22 December 2021
|
23 December 2026
|
| View |
|
DR-XY47475
|
Clobetasol Propionate
|
Timovate
|
500 mcg/g (0.05% w/w)
|
Topical Cream
|
-
|
Front Pharmaceutical PLC
|
China
|
-
|
22 October 2021
|
22 October 2026
|
| View |
|
DR-XY47476
|
Telmisartan + Hydrochlorothiazide
|
Telday H 80/25
|
80mg/25mg
|
Tablet
|
Angiotensin II Receptor Blocker-Diuretic Com
|
Torrent Pharmaceuticals Ltd.
|
India
|
Initial
|
22 October 2021
|
22 October 2026
|
| View |
|
DR-XY47477
|
Lacosamide
|
Lacasa 50
|
50 mg
|
Film-Coated Tablet
|
-
|
Cadila Healthcare Limited
|
India
|
-
|
21 October 2021
|
21 October 2024
|
| View |
|
DR-XY47478
|
Lacosamide
|
Lacasa 100
|
100 mg
|
Film-Coated Tablet
|
Antiepileptic
|
Cadila Healthcare Limited
|
India
|
Monitored Release
|
21 October 2021
|
21 October 2024
|
| View |
|
DR-XY47480
|
Lacosamide
|
Lacasa 200
|
200 mg
|
Film-Coated Tablet
|
-
|
Cadila Healthcare Limited
|
India
|
-
|
21 October 2021
|
21 October 2024
|