| View |
|
DRP-444
|
Aciclovir
|
Zealor
|
200 mg
|
Tablet
|
Antiviral
|
Flamingo Pharmaceuticals Ltd.
|
India
|
Automatic Renewal (Compliance)
|
29 March 2022
|
18 June 2027
|
| View |
DR-XY39078_PI_01.pdf
|
DR-XY39078
|
Paliperidone (as palmitate)
|
Invega Sustenna
|
150 mg/1.5 mL
|
Prolonged Release Suspension For Injection (IM)
|
Antipsychotic
|
Janssen Pharmaceutica NV
|
Belgium
|
Renewal
|
17 January 2024
|
16 February 2029
|
| View |
DR-XY39077_PI_01.pdf
|
DR-XY39077
|
Paliperidone (as palmitate)
|
Invega Sustenna
|
100 mg/mL
|
Prolonged Release Suspension For Injection (IM)
|
Antipsychotic
|
Janssen Pharmaceutica NV
|
Belgium
|
Renewal
|
23 January 2024
|
16 February 2029
|
| View |
DR-XY39079_PI_01.pdf
|
DR-XY39079
|
Paliperidone (as palmitate)
|
Invega Sustenna
|
75 mg/0.75 mL
|
Prolonged Release Suspension For Injection (IM)
|
Antipsychotic
|
Janssen Pharmaceutica NV
|
Belgium
|
Renewal
|
24 January 2024
|
16 February 2029
|
| View |
DR-XY38071_PI_01.pdf
|
DR-XY38071
|
Testosterone enantate
|
Vivrone
|
250mg/mL
|
Solution For Injection (IM)
|
-
|
Geofman Pharmaceuticals
|
Pakistan
|
Initial from Monitored Release Extension (MRE)]
|
14 August 2023
|
09 June 2025
|
| View |
|
DRP-4062-02
|
Chlorphenamine Maleate
|
None
|
5 mg
|
Tablet
|
Antihistamine (H1-Receptor Antagonist)
|
AM-Europharma Corporation
|
Philippines
|
Renewal
|
31 May 2021
|
14 June 2025
|
| View |
|
DR-XY44243
|
Lornoxicam
|
Zornica -8
|
8 mg
|
Film-Coated Tablet
|
Non-Steroidal Anti-Inflammatory Drug (NSAID)
|
Micro Labs Limited
|
India
|
Initial (from Monitored Release)
|
21 July 2022
|
24 February 2025
|
| View |
|
DR-XY38582
|
Meropenem(As Trihydrate)
|
Canem
|
1g
|
Powder for Injection (IV)
|
Antibacterial (Carbapenem)
|
Shamshree Lifesciences, Ltd.
|
India
|
Initial (from Monitored Release status)
|
06 May 2022
|
27 January 2025
|
| View |
|
DR-XY40703
|
Oxycodone hydrochloride + Naloxone hydrochloride
|
Targin
|
10 mg/5 mg
|
Prolonged-Release Tablet
|
-
|
Bard Pharmaceuticals Limited
|
United Kingdom
|
Initial (from Monitored Release Extension status)
|
08 November 2022
|
28 February 2025
|
| View |
|
DR-XY40702
|
Oxycodone Hydrochloride + Naloxone Hydrochloride
|
Targin
|
40mg/20mg
|
Prolonged-Release Tablet
|
-
|
Bard Pharmaceuticals Ltd.
|
United Kingdom
|
Initial (from Monitored release)
|
20 May 2022
|
28 February 2025
|
| View |
|
DR-XY40700
|
Oxycodone Hydrochloride + Naloxone Hydrochloride
|
Targin
|
20mg/10mg
|
Prolonged-Release Tablet
|
Opioid Analgesic
|
Bard Pharmaceuticals Ltd.
|
United Kingdom
|
Initial (from Monitored release)
|
20 May 2022
|
28 February 2025
|
| View |
|
DR-XY37762
|
Rosuvastatin (As Calcium)
|
Lipichek
|
10 mg
|
Film-Coated Tablet
|
-
|
Zim Laboratories Ltd.
|
India
|
Initial (from Monitored release)
|
30 May 2022
|
08 April 2025
|
| View |
|
DR-XY44448
|
Clopidogrel (As Bisulfate) + Aspirin
|
Ecosprin Plus
|
75 mg/ 75 mg
|
Film-Coated Tablet
|
Antithrombotic
|
The ACME Laboratories Limited
|
Bangladesh
|
Initial (from Monitored Release)
|
14 September 2022
|
10 April 2025
|
| View |
|
DR-XY40936
|
Iodixanol
|
Visipaque
|
550 mg/mL Solution for Injection (equivalent to 270
mg Iodine)
|
Solution for Injection
|
Contrast Medium (Iodinated X-ray Contrast Medium)
|
GE Healthcare Ireland Ltd.
|
Ireland
|
Initial (from Monitored Release Extension)
|
27 May 2022
|
04 June 2025
|
| View |
|
DR-XY36359
|
Gadobenate dimeglumine
|
MultiHance
|
529mg/mL (equivalent to Gadobenic acid 334 mg + Meglumine 195 mg/mL)
|
Solution For IV Injection
|
Diagnostic agent
|
Patheon Italia S.p.A.
|
Italy
|
Renewal
|
25 July 2024
|
29 July 2029
|
| View |
|
DR-XY38029
|
Metformin Hydrochloride + Glimepiride
|
Azulix 1 MF
|
500mg / 1mg
|
Tablet
|
Oral Hypoglycemic (Biguanide and Sulfonylurea)
|
Torrent Pharmaceuticals Ltd.
|
India
|
Initial (from Monitored Release)
|
30 May 2022
|
01 June 2025
|
| View |
|
DR-XY37962
|
Nebivolol (As Hydrochloride)
|
Toricard-5
|
5mg
|
Tablet
|
Beta-blocker
|
Torrent Pharmaceuticals Ltd.
|
India
|
Initial from Monitored Release Extension
|
27 May 2022
|
20 May 2025
|
| View |
|
DR-XY44056
|
Montelukast (as sodium) + Levocetirizine Hydrochloride
|
L-Zinex Duo
|
10 mg/5 mg
|
Film-Coated Tablet
|
Leukotriene Receptor Antagonist/ Antihistamine
|
Corona Remedies Pvt. Ltd.
|
India
|
Initial from Monitored-Release]
|
13 October 2022
|
14 January 2025
|
| View |
|
DR-XY34424
|
Ginkgo Biloba EGb 761
|
Tebonin Forte
|
120mg
|
Film Coated Tablet
|
Neurotropic Agent
|
Dr. Willmar Schwabe GmbH & Co. KG
|
Germany
|
Initial (from Monitored Release Extension)
|
27 April 2022
|
27 March 2025
|
| View |
|
DR-XY20680
|
Ginkgo Biloba EGb 761
|
Tebokan
|
40mg
|
Film Coated Tablet
|
Neurotropic Agent
|
Dr. Willmar Schwabe GmbH & Co. KG
|
Germany
|
Initial (from Monitored Release Extension)
|
27 April 2022
|
24 April 2025
|