| View |
|
DRP-12525
|
Cetirizine Dihydrochloride
Phenylephrine Hydrochloride
|
Zetrinx Plus
|
5mg/10mg
|
Tablet
|
Antihistamine/Nasal Decongestant
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
Initial (OTC||PCPR]
|
26 August 2022
|
26 August 2027
|
| View |
|
DRP-12527
|
Sodium Bicarbonate
|
Rcarbonate
|
650mg
|
Tablet
|
Antacid
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
Initial TOTCPCPR)
|
26 August 2022
|
26 August 2027
|
| View |
|
DRP-12554
|
Omeprazole (Sodium)
|
Medprazol IV
|
40mg
|
Powder For Injection (IV)
|
Proton Pump Inhibitor
|
Reyoung Pharmaceutical Co. Ltd.
|
China
|
Initial
|
01 September 2022
|
01 September 2027
|
| View |
DR-XY48330_PI_01.pdf
|
DR-XY48330
|
Tenofovir Alefenamide (As Fumarate)
|
HepBest
|
25 mg
|
Film-Coated Tablet
|
-
|
Mylan Laboratories Limited
|
India
|
Monitored Release
|
01 September 2022
|
01 September 2027
|
| View |
|
DR-XY48333
|
Doripenem (as monohydrate)
|
Dorpen
|
500mg
|
Powder for Injection for I.V. Infusion
|
Antibacterial (Carbapenem)
|
Brooks Steriscience Limited
|
India
|
Initial
|
01 September 2022
|
01 September 2027
|
| View |
|
DRP-12530
|
Bendamustine Hydrochloride
|
Damusin
|
25 mg
|
Lyophilized Powder for Concentrate for Solution
for IV Infusion
|
Alkylating Agent
|
Shilpa Medicare Limited
|
India
|
Initial (Revalidation)
|
26 August 2022
|
26 August 2027
|
| View |
|
DRP-12517
|
Pregabalin
|
None
|
150 mg
|
Capsule
|
Antiepileptic
|
PT. Darya-Varia Laboratoria Tbk
|
Indonesia
|
Initial
|
31 August 2022
|
31 August 2027
|
| View |
|
DRP-12516
|
Pregabalin
|
None
|
75 mg
|
Capsule
|
Antiepileptic
|
PT. Darya-Varia Laboratoria Tbk
|
Indonesia
|
Initial
|
31 August 2022
|
31 August 2027
|
| View |
|
DRP-12524
|
Furosemide
|
Kosix
|
10 mg/mL
|
Solution For Injection (I.M./I.V.)
|
Diuretic
|
Farbe Firma
|
India
|
Initial
|
26 August 2022
|
26 August 2027
|
| View |
|
DR-XY48331
|
Simvastatin
|
Simvacor
|
40 mg
|
Film-Coated Tablet
|
HMG CoA reductase inhibitor
|
Y.S.P. Industries (M) Sdn. Bhd.
|
Malaysia
|
Initial
|
01 September 2022
|
01 September 2027
|
| View |
|
DR-XY48323
|
Methylcobalamine
|
Meconerv
|
500 mg
|
Film-Coated Tablet
|
Vitamin
|
Micro Labs Limited
|
India
|
Initial
|
30 August 2022
|
30 August 2027
|
| View |
|
DR-XY48322
|
Mecobalamin
|
Meconerv
|
1 mg
|
Film-Coated Tablet
|
Vitamin
|
Micro Labs Limited
|
India
|
Initial
|
30 August 2022
|
30 August 2027
|
| View |
|
DR-XY48321
|
Mecobalamin
|
Meconerv
|
1.5 mg
|
Film-Coated Tablet
|
Vitamin
|
Micro Labs Limited
|
India
|
Initial
|
30 August 2022
|
30 August 2027
|
| View |
|
DRP-12541
|
Dobutamine
(As Hydrochloride)
|
Doburx
|
50 mg/mL
|
Solution for IV Infusion
|
Adrenergic and Dopaminegic agent
|
Farbe Firma
|
India
|
Initial
|
30 August 2022
|
30 August 2027
|
| View |
|
DRP-12545
|
Benzoic Acid + Salicylic Acid
|
Bensarex
|
120 mg/60 mg per gram
|
Ointment
|
-
|
Jiangxi Xier Kangtai Pharmaceutical Co., Ltd.
|
China
|
Initial
|
31 August 2022
|
31 August 2027
|
| View |
|
DRP-12564
|
Ascorbic Acid + Zinc
|
Nucee-Z
|
500mg/10mg
|
Film-Coated Tablet
|
Vitamin/Mineral
|
Novagen Healthcare Pvt. Ltd.
|
India
|
Renewal
|
01 March 2024
|
02 September 2029
|
| View |
|
DRP-5730-01
|
Clotrimazole + Beclomethasone Dipropionate
|
Beclo
|
1 %/0.025 % (10 mg/0.25 mg per g)
|
Topical Cream
|
Antifungal/Corticosteroid
|
Agio Pharmaceuticals Ltd
|
India
|
-
|
15 September 2022
|
18 March 2027
|
| View |
|
DRP-11812-01
|
Ascorbic Acid + Zinc
|
ProVitaCap
|
500mg (equivalent to 562.54 mg Sodium Ascorbate)/ 10mg (equivalent to 27.5 mg Zinc Sulfate) Caplet
|
|
Vitamin and Mineral
|
Pharmatechnica Laboratory Inc.
|
India
|
-
|
15 September 2022
|
02 May 2027
|
| View |
|
DRP-12610
|
Aspirin + Rosuvastatin (as calcium)
|
Rosuprin
|
80mg/10mg
|
Capsule
|
-
|
Ajanta Pharma Limited
|
India
|
-
|
15 September 2022
|
26 January 2025
|
| View |
|
DRP-12611
|
Aspirin + Rosuvastatin (as calcium)
|
Rosuprin
|
80mg/20mg
|
Capsule
|
-
|
Ajanta Pharma Limited
|
India
|
-
|
15 September 2022
|
26 January 2025
|