| 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 |
|
DRP-10636
|
Sertraline (as Hydrochloride)
|
Exsert
|
50mg
|
Film-Coated Tablet
|
-
|
XL Laboratories Pvt. Ltd.
|
India
|
-
|
26 October 2021
|
26 October 2026
|
| View |
|
DRP-9477
|
Cefuroxime (as axetil)
|
Cefukon-DS
|
125mg/5mL
|
Powder for Oral Suspension
|
-
|
Sance Laboratories Pvt. Ltd.
|
India
|
-
|
25 October 2021
|
25 October 2026
|
| View |
|
DR-XY46655
|
Paclitaxel
|
Paclisun 300
|
300 mg/2.73 mL
|
Concentrate Solution for IV Infusion
(albumin-free Concentrate for Nanodispersion)
|
Antineoplastic
|
Sun Pharmaceutical Industries Ltd., India
|
India
|
Monitored Release (Reconstruction)
|
31 July 2024
|
09 November 2026
|
| View |
|
DRP-3580
|
Cefaclor (As Monohydrate)
|
Aczebri
|
250mg
|
Capsule
|
Antibacterial
|
Shin Poong Pharmaceutical Co., Ltd.
|
Korea
|
Initial (Variation)
|
26 October 2021
|
02 June 2025
|
| 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-XY47489
|
Mupirocin
|
Bactend
|
20mg/gram (2%)
|
Ointment
|
Antibacterial
|
Front Pharmaceutical PLC
|
China
|
-
|
22 October 2021
|
22 October 2026
|
| View |
|
DR-XY47488
|
Mupirocin
|
Procin
|
20mg/gram (2% w/w)
|
Ointment
|
-
|
Front Pharmaceutical PLC
|
China
|
-
|
22 October 2021
|
22 October 2026
|
| View |
|
DR-XY47424
|
Vitamin B-Complex
|
IV Flex
|
100 mg/100 mg/1 mg per 3 mL
|
Solution for Injection
(I.M.)
|
Vitamin Combination
|
Swiss Parenterals Ltd.
|
India
|
Renewal
|
15 October 2021
|
15 October 2028
|
| View |
|
DR-XY47520
|
Peritoneal dialysis solution with 1.5% Dextrose
|
CAPD/DPCA 17 Stay Safe Link
|
Formulation: Each L of solution contains: Glucose monohydrate -16.5 g (equivalent to 15 g glucose
anhydrous) Calcium chloride dihydrate -183.8 mg
Magnesium chloride hexahydrate-101.7 mg Sodium lactate-3.925 g Sodium chloride-5.786 g
mmol/L : Ca-1.25 Na-134 Mg-0.5
C1-102.5
(S)-lactate-35 Glucose-83.2
|
Solution for Peritoneal Dialysis
|
Peritoneal Dialysis
|
Fresenius Medical Care Production Sdn. Bhd.
|
Malaysia
|
Initial (Reconstruction)
|
22 September 2022
|
09 November 2026
|
| View |
DR-XY41362_PI_01.pdf
|
DR-XY41362
|
Agomelatine
|
Valdoxan
|
25 mg
|
Film-Coated Tablet
|
-
|
Les Laboratoires Servier Industrie
|
France
|
Initial (Variation)
|
10 March 2023
|
10 March 2028
|
| View |
|
DR-XY47521
|
Oxytocin
|
Imfetus
|
10 I.U./mL
|
Solution for Injection (I.V.)
|
Posterior Pituitary Lobe Hormone
|
Sterile-Gene Life Sciences (P) Ltd.
|
India
|
Initial
|
09 November 2021
|
09 November 2026
|
| View |
|
DRP-10669
|
Hydrocortisone (as sodium succinate)
|
Hydriclex
|
100 mg
|
Powder for Injection (I.M.I.V.)
|
-
|
BioRx Pharma Labs LLP
|
India
|
-
|
03 November 2021
|
03 November 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 |
|
DRP-7330
|
Olanzapine
|
Olandus 10
|
10 mg
|
Film Coated Tablet
|
Antipsychotic
|
Cadila Healthcare Limited
|
India
|
Automatic Renewal
|
13 December 2022
|
11 March 2028
|
| View |
|
DRP-10561
|
Rasagiline
|
Rasatab 1
|
1 mg
|
Tablet
|
-
|
Remedica Ltd.
|
Cyprus
|
-
|
15 October 2021
|
15 October 2026
|
| View |
DR-XY47515_PI_01.pdf
|
DR-XY47515
|
Dexmedetomidine (as hydrochloride) in 0.9% w/v
Sodium Chloride
|
Precedex Premix
|
4 mcg/mL
|
Solution for Intravenous Infusion
|
Hypnotic/Sedative
|
Hospira, Inc.
|
United States of America
|
Monitored Release
|
05 November 2021
|
05 November 2026
|
| View |
|
DR-XY 47469
|
Prednisolone (as sodium phosphate)
|
None
|
15 mg/5 mL
|
Syrup
|
Corticosteroid
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
19 October 2021
|
19 October 2026
|
| View |
|
DRP-10423
|
Telmisartan
|
Telmitar 40
|
40mg
|
Tablet
|
-
|
Hetero Labs Limited (Unit V)
|
India
|
-
|
25 October 2021
|
25 October 2026
|
| View |
|
DRP-10424
|
Telmisartan
|
Telmitar 80
|
80mg
|
Tablet
|
-
|
Hetero Labs Limited (Unit V)
|
India
|
-
|
25 October 2021
|
25 October 2026
|