| View |
|
DRP- 1837-04
|
Mefenamic acid
|
None
|
500 mg
|
Tablet
|
-
|
Hebei Jiheng (Group) Pharmacy Co., Ltd.
|
China
|
Automatic Renewal (Reconstruction)
|
26 January 2023
|
31 January 2025
|
| View |
|
DR-XY47868
|
Rivaroxaban
|
Rivaban
|
15 mg
|
Film-Coated Tablet
|
Antithrombotic agents (direct factor Xa inhibitor)
|
Lupin Limited (Unit II)
|
India
|
Monitored Release
|
30 March 2022
|
30 March 2027
|
| View |
|
DRP-6284-01
|
Mefenamic Acid
|
None
|
50 mg / 5 mL
|
Oral Suspension
|
-
|
Drugmaker's Laboratories, Inc.
|
Philippines
|
Renewal
|
31 March 2021
|
22 March 2025
|
| View |
|
DRP-4204-03
|
Tranexamic Acid
|
Kontranex
|
500 mg
|
Capsule
|
Anti-Fibrinolytic
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
Renewal
|
19 February 2023
|
08 February 2028
|
| View |
|
DR-XY46225
|
Ascorbic Acid + Folic Acid + Cyanocobalamin
(Vitamin B12)
|
Melivit
|
413.09mg (equivalent to 500mg Calcium Ascorbate)/80mcg/20mcg
|
Capsule
|
Vitamins
|
Lejal Laboratories, Inc.
|
Philippines
|
Automatic Renewal
|
13 February 2023
|
13 February 2028
|
| View |
|
DRP-9446
|
Zoledronic Acid
|
Zobone 5
|
5 mg/100 mL
|
Solution for Injection (I.V. Infusion)
|
Bisphosphonate
|
Sun Pharmaceutical Industries Limited
|
India
|
Renewal
|
19 February 2023
|
13 August 2028
|
| View |
|
DRP-4378-03
|
Loperamide Hydrochloride
|
Lopemid
|
2 mg
|
Capsule
|
Antimotility
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Automatic Renewal
|
19 February 2023
|
18 March 2028
|
| View |
|
BR-1438
|
Candesartan
|
Torcand-32
|
32 mg
|
Tablet
|
-
|
Baxter AG
|
Austria
|
Monitored Release
|
08 February 2023
|
08 February 2028
|
| View |
DR-XY48624_PI_01.pdf
|
DR-XY48624
|
Moxifloxacin (as hydrochloride)
|
Xiflox
|
400mg
|
Film-Coated Tablet
|
-
|
Getz Pharma Pvt. Ltd.
|
Pakistan
|
Initial
|
14 February 2023
|
14 February 2028
|
| View |
|
DRP-13382
|
Fenofibrate
|
Fenoflex
|
160 mg
|
Capsule
|
Lipid Modifying Agent
|
PT Darya-Varia Laboratoria Tbk.
|
Indonesia
|
Initial (Correction)
|
07 February 2024
|
15 February 2028
|
| View |
|
DRP-13449
|
Irinotecan Hydrochloride
|
None
|
20 mg/mL (300 mg/15 mL)
|
Concentrate Solution For IV Infusion
|
-
|
Eugia Pharma Specialities Limited
|
India
|
Initial
|
22 February 2023
|
22 February 2028
|
| View |
|
DRP-13432
|
Acyclovir
|
Saphrivax
|
50 mg/g (5% w/w)
|
Cream
|
-
|
Azine Healthcare Pvt. Ltd.
|
India
|
Initial
|
17 February 2023
|
17 February 2028
|
| View |
|
DR-XY48629
|
Vinorelbine (as tartrate)
|
Vinotel
|
10 mg/mL
|
Solution For I.V. Infusion
|
-
|
Fresenius Kabi Oncology Limited.
|
India
|
Initial
|
15 February 2023
|
15 February 2028
|
| View |
|
DRP-13408
|
Febuxostat
|
Meduroxic
|
40mg
|
Film-Coated Tablet
|
-
|
Mankind Pharma Limited (Unit II)
|
India
|
Initial
|
14 February 2023
|
14 February 2028
|
| View |
|
DRP-13399
|
Mecobalamin
|
Incobal
|
500 mcg/mL
|
Solution For Injection (IM/IV)
|
-
|
Indus Pharma (Pvt.) Ltd.
|
Pakistan
|
Initial
|
15 February 2023
|
15 February 2028
|
| View |
|
DRP-13457
|
Ivabradine Hydrochloride
|
Bradirem
|
5 mg
|
Film-Coated Tablet
|
-
|
Remedica Ltd.
|
Cyprus
|
Initial
|
22 February 2023
|
22 February 2028
|
| View |
|
DRP-13456
|
Ivabradine Hydrochloride
|
Bradirem
|
7.5 mg
|
Film-Coated Tablet
|
-
|
Remedica Ltd.
|
Cyprus
|
Initial
|
22 February 2023
|
22 February 2028
|
| View |
|
DRP-13444
|
Gemcitabine (As Hydrochloride)
|
Emcisanz-1000
|
1 g
|
Powder for Solution for I.V. Infusion
|
-
|
Admac Lifesciences
|
India
|
Initial
|
20 February 2023
|
20 February 2028
|
| View |
|
DR-XY48620
|
Ipratropium Bromide
|
Ipramide
|
250mcg/mL (500mcg/2mL)
|
Solution for Inhalation
|
-
|
Jewim Pharmaceutical (Shandong) Co., Ltd.
|
China
|
Initial
|
14 February 2023
|
14 February 2028
|
| View |
|
DR-XY48619
|
Nicardipine Hydrochloride
|
Nicafar
|
1mg/mL
|
Solution For IV Infusion
|
-
|
Scott-Edil Pharmacia Limited
|
India
|
Initial
|
15 February 2023
|
15 February 2028
|