View |
|
DRP-10534-01
|
Celecoxib
|
Gicox
|
200 mg
|
Capsule
|
Non- steroidal Anti-inflammatory Drug (COX-2 Selective Inhibitor)
|
Kopran Limited
|
India
|
-
|
07 June 2022
|
12 October 2026
|
View |
|
DRP-8640-05
|
Azithromycin (as dihydrate)
|
Gizith
|
500 mg
|
Film-Coated Tablet
|
Antibacterial (Macrolide)
|
Theon Pharmaceuticals Limited
|
India
|
-
|
07 June 2022
|
22 January 2025
|
View |
|
DRP-8706-01
|
Rosuvastatin (as calcium)
|
Govastatin
|
10 mg
|
Film-Coated Tablet
|
HMG CoA Reductase Inhibitor
|
Gracure Pharmaceutical Ltd.
|
India
|
-
|
16 February 2022
|
07 February 2025
|
View |
|
DRP-12069
|
Ascorbic Acid
|
Poten-cee
|
100mg/ml
|
Syrup (Oral Drops)
|
Vitamin
|
Pascual Laboratories, Inc.
|
Philippines
|
Renewal
|
07 April 2024
|
21 June 2029
|
View |
|
DRP-7827
|
Cefaclor (as Monohydrate)
|
Rimaclor
|
50mg/ mL
|
Granules for Suspension (Oral Drops)
|
Antibacterial (Cephalosporin)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Automatic Renewal
|
07 December 2021
|
02 January 2027
|
View |
|
DRP-8576
|
Hydroquinone
|
None
|
40mg/g (4% w/w)
|
Topical Cream
|
Other Dermatologicals
|
Stalder Laboratories, Inc.
|
Philippines
|
Automatic Renewal
|
16 March 2022
|
25 May 2027
|
View |
|
DRP-986
|
Metronidazole
|
Flamibazid 500
|
500 mg
|
Tablet
|
Antibacterial/Antiprotozoal (Nitroimidazole)
|
Flamingo Pharmaceuticals Ltd.
|
India
|
Automatic Renewal
|
14 March 2022
|
13 June 2027
|
View |
|
DR-XY15253-B
|
Cefalexin (As Monohydrate)
|
Infexin
|
500 mg
|
Capsule
|
Antibacterial (Cephalosporin)
|
Lloyd Laboratores, Inc.
|
Philippines
|
Automatic Renewal
|
11 April 2022
|
02 May 2027
|
View |
BR-1413_PI_01.pdf
|
BR-1413
|
Semaglutide
|
Rybelsus
|
3 mg
|
Tablet
|
Glucagon-like Peptide-1 (GLP-1) Analogue
|
Novo Nordisk A/S
|
Denmark
|
Monitored Release
|
18 August 2022
|
18 August 2027
|
View |
|
DRP-12490
|
Cholecalciferol
|
Sydenferol
|
6mg (equivalent to 600IU)
|
Capsule
|
Vitamin
|
Sydenham Laboratories, Inc.
|
Philippines
|
Initial (OTC||PCPR)
|
19 August 2022
|
19 August 2027
|
View |
|
DRP-12491
|
Orlistat
|
Sydenslim
|
120 mg
|
Capsule
|
Peripherally Acting Antiobesity Product
|
Sydenham Laboratories, Inc.
|
Philippines
|
Initial (OTC)[PCPR]
|
19 August 2022
|
19 August 2027
|
View |
DR-XY48317_PI_01.pdf
|
DR-XY48317
|
Tadalafil
|
Torfil 20
|
20 mg
|
Film-Coated Tablet
|
Phosphodiesterase Type 5 (PDE5) Inhibitor
|
Torrent Pharmaceuticals Ltd.
|
india
|
Initial
|
26 August 2022
|
26 August 2027
|
View |
|
BR-1409
|
Epoetin Alfa
|
Erysaa
|
4,000 IU/0.4 mL
|
Solution for Injection (IV)
|
-
|
PanGen Biotech Inc.
|
Korea
|
Initial
|
16 August 2022
|
16 August 2027
|
View |
|
DR-XY48300
|
Pantoprazole (As Sodium Sesquihydrate)
|
Conpanzole
|
20 mg
|
Enteric-Coated Tablet
|
Proton Pump Inhibitor
|
Y.S.P. Industries (M) Sdn. Bhd.
|
Malaysia
|
Initial
|
18 August 2022
|
18 August 2027
|
View |
|
DRP-12499
|
Escitalopram (AS Oxalate)
|
Citapram
|
5mg
|
Film-Coated Tablet
|
Antidepressant (Selective Serotonin Reuptake Inhibitor)
|
Globela Pharma Private Limited
|
India
|
Initial
|
16 August 2022
|
19 August 2027
|
View |
|
DRP-12498
|
Escitalopram (AS Oxalate)
|
Citapram
|
10mg
|
Film-Coated Tablet
|
-
|
Globela Pharma Private Limited
|
India
|
Initial
|
19 August 2022
|
19 August 2027
|
View |
|
DRP-12497
|
Escitalopram (As Oxalate)
|
Citapram
|
20mg
|
Film-Coated Tablet
|
-
|
Globela Pharma Private Limited
|
India
|
Initial
|
19 August 2022
|
19 August 2027
|
View |
|
DRP-12509
|
Vitamin B1+B6+B12
|
Flexanerv
|
300mg/300mg/1000mcg
|
Capsule
|
Vitamin
|
Fredun Pharmaceuticals Limited
|
India
|
Initial (OTC)
|
25 August 2022
|
25 August 2027
|
View |
|
DRP-12514
|
Clarithromycin
|
Claritrol
|
500 mg
|
Film-Coated Tablet
|
Antibacterial (Macrolide)
|
Fredun Pharmaceuticals Limited
|
india
|
Initial (correction)
|
13 February 2023
|
25 August 2027
|
View |
|
DRP-12436
|
Iron
|
Fesusaph-8.8
|
8.8 mg (equivalent to 44 mg Ferrous Sulfate
Heptahydrate)/5 mL
|
Syrup (Orange Flavor)
|
Mineral (Anti-anemia)
|
Azine Healthcare Pvt. Ltd.
|
India
|
Initial (OTC)
|
18 August 2022
|
18 August 2027
|