| View |
|
DR-XY47813
|
Sterile Water For Injection
|
None
|
50mL and 100mL
|
Solution for Injection
|
Solvent/Diluent
|
Shijiazhuang No.4 Pharmaceutical Co., Ltd.
|
China
|
Initial
|
14 March 2022
|
14 March 2027
|
| View |
|
DRP-11450
|
Montelukast (As Sodium)
|
None
|
5 mg
|
Chewable Tablet
|
Leukotriene Receptor Antagonist
|
Aurobindo Pharma Limited - Unit VII
|
India
|
Initial (Reconstruction)
|
27 May 2022
|
14 March 2025
|
| View |
|
DR-XY47817
|
Montelukast (As Sodium)
|
Montela 10
|
10mg
|
Film-Coated Tablet
|
Leukotriene Receptor Antagonist
|
Delta Pharma Ltd.
|
Bangladesh
|
Initial (Reconstruction)
|
14 July 2022
|
14 March 2027
|
| View |
|
DRP-11506
|
Montelukast (as sodium)
|
None
|
10 mg
|
Film-Coated Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
-
|
17 March 2022
|
17 March 2027
|
| View |
|
DRP-11507
|
Montelukast (as sodium)
|
Montefast
|
10 mg
|
Film-Coated Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
-
|
17 March 2022
|
17 March 2027
|
| View |
|
DRP-11508
|
Montelukast (as sodium)
|
Montecare
|
10 mg
|
Film-Coated Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
-
|
17 March 2022
|
17 March 2027
|
| View |
|
DRP-11509
|
Montelukast (as sodium)
|
Montair
|
10 mg
|
Film-Coated Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
-
|
17 March 2022
|
17 March 2027
|
| View |
|
DR-XY47826
|
Meropenem
|
Meroz
|
500 mg
|
Powder for injection (IV)
|
-
|
Dongkwang Pharma. Co., Ltd.
|
Korea
|
Initial [Rx]
|
12 May 2022
|
16 March 2027
|
| View |
|
DRP-11480
|
Meropenem
|
Merop
|
1 g
|
Powder For Injection (IV)
|
-
|
PT. Darya-Varia Laboratoria Tbk
|
Indonesia
|
-
|
16 March 2022
|
16 March 2027
|
| View |
|
DRP-11479
|
Meropenem
|
Merop
|
500 mg
|
Powder For Injection (IV)
|
-
|
PT. Darya-Varia Laboratoria Tbk
|
Indonesia
|
-
|
16 March 2022
|
16 March 2027
|
| View |
|
DR-XY47507
|
Paracetamol
|
Leniol
|
1 g/ 100 ml
|
Solution for IV Infusion
|
Analgesic/ Antipyretic
|
Otsuka Pharmaceutical India Private Limited
|
India
|
Initial
|
15 March 2022
|
15 March 2027
|
| View |
|
HMRP-42
|
Coleus amboinicus Lour. (Oregano) Leaf
|
Herbamed
|
125mg/5mL
|
Syrup (Bubblegum, Tutti-Frutti, and
Menthol Flavor)
|
Expectorant
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial
|
11 March 2022
|
11 March 2027
|
| View |
|
DRP-11493
|
L-Ornithine L-Asparate
|
Hepabil
|
5g/10mL
|
Concentrate Solution For Intravenous (IV) Infusion
|
-
|
Venus Remedies
|
India
|
-
|
16 March 2022
|
16 March 2027
|
| View |
|
DRP-11448
|
Fusidic Acid
|
Fustadin
|
20 mg/g (2% w/w)
|
Topical Cream
|
Antibiotic
|
Y.S.P. Industries (M) Sdn. Bhd.
|
Malaysia
|
Initial
|
14 March 2022
|
14 March 2027
|
| View |
|
DRP-11447
|
Fusidic Acid + Betamethasone Dipropionate
|
Fusidasol
|
20 mg/500mcg per g (2%/0.05% w/w)
|
Topical Cream
|
Antibiotic-Corticosteroid Combination
|
Y.S.P. Industries (M) Sdn. Bhd.
|
Malaysia
|
Initial
|
14 March 2022
|
14 March 2027
|
| View |
|
DR-XY47819
|
Metronidazole
|
Frotin
|
250 mg
|
Vaginal Suppository
|
-
|
Y.S.P. Industries (M) SDN. BHD.
|
Malaysia
|
-
|
15 March 2022
|
15 March 2027
|
| View |
|
DRP-11461
|
Febuxostat
|
Febumed-80
|
80mg
|
Film Coated Tablet
|
Antigout
|
Acme Formulation Pvt. Ltd.
|
India
|
Initial
|
15 March 2022
|
15 March 2027
|
| View |
|
DRP-11449
|
Esomeprazole (As Sodium)
|
Esonex IV
|
40mg
|
Lyophilized Powder for Solution for I.V. Injection/Infusion
|
Proton Pump Inhibitor
|
Sofarimex - Industria Quimica e Farmaceutica, S.A.
|
Portugal
|
Initial
|
14 March 2022
|
14 March 2027
|
| View |
|
DR-XY47811
|
Hydrocortisone (as sodium succinate)
|
None
|
100 mg
|
Powder for Injection (I.M./I.V.)
|
Corticosteroid
|
Karnataka Antibiotics & Pharma Ltd.
|
India
|
Initial
|
11 March 2022
|
11 March 2027
|
| View |
|
DRP-11455
|
Ciprofloxacin (As Hydrochloride)
|
Ciprogyl
|
2 mg/mL (200 mg/100 mL)
|
Solution for Intravenous Injection
|
Antibacterial (Fluoroquinolone)
|
Unique Pharmaceutical Laboratories (A Division of
J.B. Chemicals & Pharmaceuticals Ltd.)
|
India
|
Initial
|
14 March 2022
|
14 March 2027
|