| View |
|
DR-XY47711
|
Sultamicillin tosilate
|
Sultagold
|
750 mg
|
Film-Coated Tablet
|
Antibacterial (Penicillin/Beta-Lactamase Inhibitor)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
09 February 2022
|
09 February 2027
|
| View |
|
DRP-11134
|
Pemetrexed (as disodium)
|
Pemeta-500
|
500 mg
|
Powder for Concentrate Solution IV Infusion
|
Antineoplastic
|
Admac Lifesciences
|
India
|
Initial (Reconstruction)
|
31 July 2024
|
20 January 2028
|
| View |
|
DRP-11132
|
Pemetrexed (as disodium)
|
Pemcord-1000
|
1g
|
Lyophilized Powder For Solution For IV Infusion
|
Antineoplastic
|
Intas Pharmaceuticals Limited
|
India
|
Initial
|
04 February 2022
|
04 February 2027
|
| View |
|
DRP-11182
|
Montelukast (as Sodium) + Levocetirizine hydrochloride
|
Levoplus
|
10mg/5mg
|
Tablet
|
Leukotriene Receptor Antagonist-Antihistamine Combination
|
Mankind Pharma Limited (Unit II)
|
India
|
Monitored Release
|
11 February 2022
|
11 February 2027
|
| View |
|
DRP-11140
|
Doxorubicin Hydrochloride
|
None
|
2 mg/mL (50mg/25mL)
|
Solution for Liposomal Injection (IV)
|
Antineoplastic (Anthracycline)
|
Celon Laboratories Private Limited
|
India
|
Initial
|
08 February 2022
|
08 February 2027
|
| View |
|
DRP-11141
|
Doxorubicin Hydrochloride
|
None
|
2 mg/mL (20mg/ 10mL)
|
Solution for Liposomal Injection (IV)
|
Antineoplastic (Anthracycline)
|
Celon Laboratories Private Limited
|
India
|
Initial
|
08 February 2022
|
08 February 2027
|
| View |
|
DRP-11130
|
Fexofenadine hydrochloride
|
None
|
120 mg
|
Film-Coated Tablet
|
Antihistamine
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
04 February 2022
|
04 February 2027
|
| View |
|
DRP-11129
|
Fexofenadine Hydrochloride
|
None
|
90 mg
|
Film-Coated Tablet
|
Antihistamine
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
04 February 2022
|
04 February 2027
|
| View |
|
DRP-11133
|
Fexofenadine Hydrochloride
|
None
|
60 mg
|
Film-Coated Tablet
|
Antihistamine
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
04 February 2022
|
04 February 2027
|
| View |
|
DRP-11119
|
Palonosetron (as hydrochloride)
|
Lonoxie
|
50 mcg/mL (250 mcg/5 mL)
|
Solution for Intravenous Injection
|
Antiemetic/Antinauseant [Serotonin (5HT3)
Antagonist]
|
USV Private Limited
|
India
|
Monitored Release
|
04 February 2022
|
04 February 2027
|
| View |
|
DRP-11120
|
Palonosetron (as hydrochloride)
|
None
|
50 mcg/mL (250 mcg/5 mL)
|
Solution for Intravenous Injection
|
Antiemetic/Antinauseant [Serotonin (5HT3)
Antagonist]
|
USV Private Limited
|
India
|
Monitored Release
|
04 February 2022
|
04 February 2027
|
| View |
|
DRP-11131
|
Pregabalin
|
None
|
75 mg
|
Capsule
|
Antiepileptic
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
04 February 2022
|
04 February 2027
|
| View |
|
DRP-11190
|
Montelukast (as sodium) + Levocetirizine
hydrochloride
|
Monticope
|
10mg/5mg
|
Tablet
|
Leukotriene Receptor Antagonist-Antihistamine Combination
|
Mankind Pharma Limited (Unit II)
|
India
|
Monitored Release
|
11 February 2022
|
11 February 2027
|
| View |
|
DRP-11125
|
Montelukast (as sodium)
|
Monteclair
|
5 mg
|
Chewable Tablet
|
Leukotriene Receptor Antagonist
|
Drugmaker's Laboratories, Inc.
|
Philippines
|
Initial
|
04 February 2022
|
04 February 2027
|
| View |
DR-XY47725_PI_01.pdf
|
DR-XY47725
|
Luseogliflozin (as hydrate)
|
Luseco
|
2.5 mg
|
Film-Coated Tablet
|
Blood Glucose Lowering Drug [Sodium-Glucose Co
Transporter 2 (SGLT2) Inhibitor]
|
Taisho Pharmaceutical Co., Ltd. (Omiya Factory)
|
Japan
|
Monitored Release
|
11 February 2022
|
11 February 2025
|
| View |
DR-XY47724_PI_01.pdf
|
DR-XY47724
|
Luseogliflozin (as hydrate)
|
Luseco
|
5 mg
|
Film-Coated Tablet
|
-
|
Taisho Pharmaceutical Co., Ltd. (Omiya Factory)
|
Japan
|
-
|
11 February 2022
|
11 February 2025
|
| View |
|
DRP-11181
|
Doxorubicin Hydrochloride
|
Lippod 50
|
2 mg/mL (50 mg/25mL)
|
Solution for Liposomal Injection (IV)
|
Antineoplastic (Anthracycline)
|
Celon Laboratories Private Limited
|
India
|
Initial
|
09 February 2022
|
09 February 2027
|
| View |
|
DRP-11180
|
Doxorubicin Hydrochloride
|
Lippod 20
|
2 mg/mL (20mg/ 10mL)
|
Solution for Liposomal Injection (IV)
|
Antineoplastic (Anthracycline)
|
Celon Laboratories Private Limited
|
India
|
Initial
|
09 February 2022
|
09 February 2027
|
| View |
|
DRP-2188
|
Rosuvastatin (as calcium)
|
Lipichek
|
20 mg
|
Film-Coated Tablet
|
HMG-CoA Reductase Inhibitor
|
Zim Laboratories Ltd.
|
India
|
Monitored Release
|
03 February 2022
|
04 December 2024
|
| View |
|
DRP-1944-01
|
Hyoscine-N-Butylbromide
|
Hyospan
|
10 mg
|
Tablet
|
Anticholinergic
|
Drugmaker's Laboratories, Inc.
|
Philippines
|
Renewal
|
15 March 2024
|
22 March 2029
|