| View |
|
DR-XY48148
|
Gadoteric Acid
|
Cyclolux
|
0.5 mmol/mL (equivalent to 279.32 mg/mL)
|
Solution
for Injection (IV)
|
Paramagnetic Contrast Media
|
Sanochemia Pharmazeutika GmbH
|
Austria
|
Initial
|
30 June 2022
|
30 June 2027
|
| View |
|
DR-XY48125
|
Remifentanil (as hydrochloride)
|
None
|
5 mg
|
Lyophilized Powder for Solution for Injection or Infusion (IV)
|
Opioid Anaesthetic
|
Laboratorios Normon, S.A.
|
Spain
|
Initial
|
21 June 2022
|
21 June 2027
|
| View |
|
DR-XY48124
|
Remifentanil (as hydrochloride)
|
None
|
2 mg
|
Lyophilized Powder for Solution for Injection or Infusion (IV)
|
Opioid Analgesic
|
Laboratorios Normon, S.A.
|
Spain
|
Initial
|
21 June 2022
|
21 June 2027
|
| View |
|
DR-XY48119
|
Montelukast (as sodium) + Levocetirizine Hydrochloride
|
Zykast
|
10 mg/ 5 mg
|
Tablet
|
Leukotriene Receptor Antagonist/ Antihistamine
|
Ajanta Pharma Limited
|
India
|
Initial
|
21 June 2022
|
21 June 2027
|
| View |
|
DRP-12154
|
Atorvastatin (as Calcium)
|
Zydusatorva 80
|
80 mg
|
Film Coated Tablet
|
HMG CoA reductase inhibitor
|
Cadila Healthcare Limited
|
India
|
Initial
|
22 June 2022
|
22 June 2027
|
| View |
|
DRP-11915
|
Vancomycin (As Hydrochloride)
|
Vancory
|
500 mg
|
Powder For Injection
|
Antibacterial (Glycopeptide)
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
28 June 2022
|
28 June 2027
|
| View |
|
DRP-12159
|
Dutasteride + Tamsulosin Hydrochloride
|
Uriflo-D
|
500 mcg/400 mcg
|
Capsule
|
Drugs Used in Benign Prostatic Hypertrophy
(Alpha-adrenoreceptor antagonist)
|
Ravenbhel Healthcare Private Limited
|
India
|
Initial
|
24 June 2022
|
24 June 2027
|
| View |
DR-XY48145_PI_01.pdf
|
DR-XY48145
|
Ritonavir
|
Tonavir
|
100 mg
|
Film Coated Tablet
|
Antiretroviral (Protease Inhibitor)
|
Hetero Labs Limited
|
India
|
Monitored Release
|
29 June 2022
|
29 June 2027
|
| View |
|
DRP-12152
|
Sultamicillin (as tosylate dihydrate)
|
Sultabac-750
|
750 mg
|
Film-Coated Tablet
|
Antibacterial (Penicillin/Beta-Lactamase Inhibitor)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
22 June 2022
|
22 June 2027
|
| View |
|
DRP-12153
|
Sultamicillin (as tosylate dihydrate)
|
Sultabac-375
|
375 mg
|
Film-Coated Tablet
|
Antibacterial (Penicillin/Beta-Lactamase Inhibitor)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
22 June 2022
|
22 June 2027
|
| View |
|
DR-XY48136
|
Rosuvastatin (as calcium)
|
Rosucol
|
5 mg
|
Film-Coated Tablet
|
HMG COA Reductase Inhibitor
|
Ajanta Pharma Limited
|
India
|
Initial
|
27 June 2022
|
27 June 2027
|
| View |
DR-XY39364_PI_01.pdf
|
DR-XY39364
|
Eltrombopag (as Olamine)
|
Revolade
|
25 mg
|
Film-Coated Tablet
|
-
|
Novartis Farmaceutica, SA
|
Spain
|
Initial (from Monitored Release)
|
27 June 2022
|
27 June 2027
|
| View |
DR-XY39363_PI_01.pdf
|
DR-XY39363
|
Eltrombopag (as olamine)
|
Revolade
|
50 mg
|
Film-Coated Tablet
|
Antihemorrhagic
|
Lek Pharmaceuticals d.d.
|
Slovenia
|
Initial (Variation)
|
26 June 2024
|
26 June 2029
|
| View |
|
BR-1405
|
Rituximab
|
Redditux
|
10mg/mL
|
Concentrate For Solution For Infusion (IV)
|
-
|
Dr. Reddy's Laboratories Ltd.
|
India
|
Initial
|
21 June 2022
|
21 June 2027
|
| View |
|
DRP-12198
|
Phospholipids + Multivitamins
|
Phosphomax
|
Formulation: Each capsule contains: Phospholipids ...
300mg a-tocopheryl Acetate (Vitamin E) ........................ 6mg Thiamine Mononitrate (Vitamin B1) .................... 6mg Riboflavin (Vitamin B2) .............. .................. 6mg Nicotinamide (Vitamin B3) ............
............... 30mg Pyridoxine Hydrochloride (Vitamin B6) .... . . . . . . . . ... 6 mg Cyanocobalamin (Vitamin B12) ........................ 6mcg
|
Capsule
|
Liver Therapy
|
Drugmaker's Laboratories, Inc.
|
Philippines
|
Initial
|
30 June 2022
|
30 June 2027
|
| View |
|
DRP-12167
|
Palonosetron (as hydrochloride)
|
Palset
|
50 mcg/mL (250 mcg 15 mL)
|
Solution for Intravenous Injection
|
-
|
Intas Pharmaceuticals Limited
|
India
|
Initial
|
23 June 2022
|
23 June 2027
|
| View |
|
DR-XY48141
|
Montelukast (as sodium) + Levocetirizine Hydrochloride
|
Montior
|
10 mg/5 mg
|
Film Coated Tablet
|
Leukotriene Receptor Antagonist/ Antihistamine
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial
|
29 June 2022
|
29 June 2027
|
| View |
|
DRP-12168
|
Metoprolol Tartrate
|
Loprexo
|
50 mg
|
Tablet
|
Selective beta-blocking Agent
|
CSPC Ouyi Pharmaceutical Co., Ltd.
|
China
|
Initial
|
28 June 2022
|
28 June 2027
|
| View |
|
DRP–12209
|
Levocarnitine
|
Lecarnita
|
200 mg/mL (1000 mg/5 mL)
|
Solution for Injection (I.V.)
|
Amino acids and derivatives
|
Help S.A.
|
Greece
|
Initial (Correction)
|
18 October 2022
|
30 June 2027
|
| View |
DR-XY48127_PI_01.pdf
|
DR-XY48127
|
Tadalafil + Tamsulosin hydrochloride
|
Gugutams
|
5 mg/400 mcg
|
Capsule [contains one (1) Film-Coated Tadalafil and Tamsulosin HCl pellets]
|
Alpha-adrenoreceptor Antagonist
|
Hanmi Pharmaceutical Co., Ltd.
|
Korea
|
Monitored Release (MR)
|
21 June 2022
|
21 June 2027
|