| View |
|
HMR-25
|
Astralagus membranaceus (Radix astragali)- 227.5mg
Angelica sinensis (Chinese angelica)-162.5mg Herba solani lyrati (Lyrate nightshade)-130mg Herba solani nigra (Long kui cao)-130mg
|
Zilongjin
|
N/I
|
Tablet
|
-
|
Tianjin Zhongxin Pharmaceutical Group Corporation Limited Longshunrong Pharmaceutical Factory
|
China
|
Renewal
|
05 August 2022
|
15 May 2025
|
| View |
|
DRP-12388
|
Benzydamine(As Hydrochloride)
|
Mediflam
|
3mg/mL (0.3% w/v)
|
Throat Spray (Mint Flavor)
|
Non-Steroidal Anti-inflammatory Drug (NSAID)
|
Interthai Pharmaceutical Manufacturing Ltd.
|
Thailand
|
Initial (OTC)(PCPR)
|
29 July 2022
|
29 July 2027
|
| View |
|
DRP-12389
|
Benzydamine(As Hydrochloride)
|
Mediflam
|
3mg/mL (0.3% w/v)
|
Throat Spray (Lemon Flavor)
|
Non-Steroidal Anti-Inflammatory Drug (NSAID)
|
Interthai Pharmaceutical Manufacturing Ltd.
|
Thailand
|
Initial (OTC)(PCPR)
|
29 July 2022
|
29 July 2027
|
| View |
|
DR-XY48255
|
Clindamycin (as phosphate)
|
Banbakt
|
100 mg
|
Vaginal Suppository
|
Antibiotic
|
Kusum Healthcare Pvt. Ltd.
|
India
|
Monitored Release
|
03 August 2022
|
03 August 2027
|
| View |
|
DRHR-2145
|
Troclosene Sodium
|
Aquatabs
|
1.67g
|
Effervescent Water Purification Tablet
|
Water Disinfectant
|
Medentech Limited
|
Ireland
|
Renewal
|
08 September 2024
|
05 August 2029
|
| View |
|
DRHR-2144
|
Troclosene Sodium
|
Aquatabs
|
8.68 g
|
Effervescent Water Purification Tablet
|
Water Disinfectant
|
Medentech Limited
|
Ireland
|
Renewal
|
25 August 2024
|
05 August 2029
|
| View |
|
DRP-12384
|
Multivitamins
|
Enerboss
|
Each tablet contains: Ascorbic Acid (Vitamin C)-500mg Thiamine Mononitrate (Vitamin B1)-50mg Nicotinamide (Vitamin B3)-50mg Riboflavin (Vitamin B2)-20mg
Calcium Pantothenate (Vitamin B5)-20mg
Pyridoxine HCl (Vitamin B6)-5mg Cyanocobalamin (Vitamin B12)-5 mcg
|
Film-Coated Tablet
|
Vitamins
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial (OTC)(PCPR)
|
29 July 2022
|
29 July 2027
|
| View |
|
DRP-12385
|
Multivitamins
|
Raphibon
|
Each tablet contains: Ascorbic Acid (Vitamin C)-500mg Thiamine Mononitrate (Vitamin B1)-50 mg Nicotinamide (Vitamin B3)-50mg Riboflavin (Vitamin B2)-20 mg Calcium Pantothenate (Vitamin B5)-20 mg
50mg Pyridoxine HCl (Vitamin B6)- 5mg Cyanocobalamin (Vitamin B12)-5mcg
|
Film-Coated Tablet
|
-
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial (OTC)(PCPR)
|
29 July 2022
|
29 July 2027
|
| View |
DR-XY48267_PI_01.pdf
|
DR-XY48267
|
Darunavir
|
Danavir 400
|
400mg
|
Film Coated Tablet
|
Antiviral (Protease Inhibitor)
|
Hetero Labs Limited (Unit III)
|
India
|
Monitored Release
|
10 August 2022
|
10 August 2025
|
| View |
DR-XY48268_PI_01.pdf
|
DR-XY48268
|
Darunavir
|
Danavir 600
|
600mg
|
Film Coated Tablet
|
Antiviral (Protease Inhibitor)
|
Hetero Labs Limited (Unit III)
|
India
|
Monitored Release
|
10 August 2022
|
10 August 2025
|
| View |
|
DRP-12399
|
Cefazolin (As Sodium)
|
Cefavex
|
1 g
|
Powder for Injection (IM/IV)
|
Antibacterial (Cephalosporin)
|
NPC Hebei Huamin Pharmaceutical Co., Ltd.
|
China
|
Initial
|
02 August 2022
|
02 August 2027
|
| View |
|
DR-XY48248
|
Docetaxel
|
Doxel
|
20 mg/mL
|
Concentrate for Solution for IV Infusion
|
Antineoplastic Agent
|
Sichuan Huiyu Pharmaceutical Company Limited
|
China
|
Initial
|
02 August 2022
|
02 August 2027
|
| View |
|
HMR-173
|
Blumea Balsamifera L. (Sambong) Leaf
|
None
|
500 mg
|
Tablet
|
-
|
La Croesus Pharma, Inc.
|
Philippines
|
Initial (OTC)
|
29 July 2022
|
29 July 2027
|
| View |
|
DR-XY48272
|
Lenalidomide
|
Linadex 5
|
5mg
|
Capsule
|
-
|
Hetero Labs Limited (Unit-V, Block-VB)
|
India
|
Monitored Release
|
10 August 2022
|
10 August 2025
|
| View |
|
DRP-12422
|
Pregabalin
|
None
|
150 mg
|
Capsule
|
Antiepileptic
|
Phil. United Pharma Corp.
|
Philippines
|
Initial
|
08 August 2022
|
08 August 2027
|
| View |
|
DRP-12419
|
Pregabalin
|
Pregab
|
150 mg
|
Capsule
|
Antiepileptic
|
Phil. United Pharma Corp.
|
Philippines
|
Initial
|
08 August 2022
|
08 August 2027
|
| View |
|
DRP-12418
|
Cefepime (as Hydrochloride) with Argine
|
None
|
1g
|
Powder For Injection (IM/IV)
|
Cephalosporin
|
NCPC Hebei Huamin Pharmaceutical Company Limited
|
China
|
Initial
|
04 August 2022
|
04 August 2027
|
| View |
|
DR-XY48266
|
Escitalopram (As Oxalate)
|
Escit
|
20mg
|
Film Coated Tablets
|
-
|
Celogen Generics Private Ltd.
|
India
|
Initial
|
10 August 2022
|
10 August 2027
|
| View |
|
DRP-12412
|
Losartan Potassium
|
Azartan
|
50 mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Antagonist
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial
|
03 August 2022
|
03 August 2025
|
| View |
|
DRP-12449
|
Idarubicin Hydrochloride
|
Idacord 5
|
5mg/5mL
|
Concentrate Solution For Injection (IV)
|
-
|
Intas Pharmaceuticals Limited
|
India
|
Initial
|
10 August 2022
|
10 August 2027
|