| View |
|
DRP-13846
|
Glimepiride
|
Glimphage
|
4mg
|
Tablet
|
-
|
Globela Pharma Private Limited
|
India
|
Initial
|
15 May 2023
|
15 May 2028
|
| View |
|
DRP-13899
|
0.9% Sodium Chloride
|
none
|
9 mg/mL (0.9% w/v)
|
Solution for Intravenous Infusion
|
-
|
Chimin Health Management Co., Ltd.
|
China
|
Initial
|
15 May 2023
|
28 May 2028
|
| View |
|
DRP-13900
|
0.9% Sodium Chloride
|
none
|
9mg/mL (0.9% w/v)
|
Solution for Intravenous Infusion
|
-
|
Chimin Health Management Co., Ltd.
|
China
|
Initial
|
15 May 2023
|
15 May 2028
|
| View |
|
BR-1062
|
Epoetin Beta
|
Recormon
|
10,000 IU/0.6 mL
|
Solution For Injection (IV/SC)
|
-
|
Roche Diagnostics GmbH
|
Germany
|
Renewal
|
12 May 2023
|
17 March 2028
|
| View |
|
THPR-62
|
Hedera helix (Ivy Leaf Powder Extract) + Glycyrrhiza glabra (Licorice Powder Extract) + Thymus vulgaris (Thyme Powder Extract)
|
Olcuf Plus
|
70mg/ 43.4mg/ 43mg per 10mL
|
Syrup
|
Traditionally Used Herbal Product: Relief of cough
and throat irritation.
|
Herbion Pakistan (Pvt.), Limited.
|
Pakistan
|
Initial
|
09 May 2023
|
09 May 2025
|
| View |
|
DRP-13894
|
Gabapentin
|
Saphbapentin
|
100 mg
|
Capsule
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
12 May 2023
|
12 May 2028
|
| View |
|
DRP-13880
|
Acetylcysteine
|
Acetylnova
|
200 mg
|
Granules For Oral Solution
|
-
|
Saga Lifesciences Limited
|
India
|
Initial
|
12 May 2023
|
12 May 2028
|
| View |
|
DRP-13856
|
Rosuvastatin (as calcium)
|
Arteon
|
20 mg
|
Film Coated Tablet
|
-
|
Interphil Laboratories, Inc.
|
Philippines
|
Initial
|
12 May 2023
|
12 May 2028
|
| View |
|
DR-XY48723
|
Paracetamol
|
Frecetamol
|
10 mg/mL
|
Solution for Infusion
|
-
|
Fresenius Kabi Deutschland GmbH
|
Germany
|
Initial
|
10 May 2023
|
10 May 2028
|
| View |
|
DRP-13887
|
Linezolid
|
Farzolid
|
600 mg
|
Film-Coated Tablet
|
-
|
Healer's Lab (Unit II)
|
India
|
Initial
|
12 May 2023
|
12 May 2028
|
| View |
|
DRP-13890
|
Sitagliptin (as phosphate monohydrate) +
Metformin Hydrochloride
|
none
|
50 mg/500 mg
|
Film-Coated Tablet
|
-
|
Bafna Pharmaceuticals Limited
|
India
|
Initial
|
11 May 2023
|
11 May 2028
|
| View |
|
DRP-13906
|
Gabapentin
|
Gabaknock
|
300 mg
|
Capsule
|
Antiepileptic
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial
|
16 May 2023
|
16 May 2028
|
| View |
|
DRP-13881
|
Febuxostat
|
None
|
40mg
|
Film-Coated Tablet
|
-
|
Globela Pharma Private Limited
|
India
|
Initial
|
11 May 2023
|
11 May 2028
|
| View |
|
DR-XY48727
|
Febuxostat
|
Fegout
|
40 mg
|
Film-Coated Tablet
|
-
|
Koera United Pharm. Inc.
|
Korea
|
Initial
|
15 May 2023
|
15 May 2028
|
| View |
DRP-13879_PI_01.pdf
|
DRP-13879
|
Esomeprazole (as magnesium trihydrate)
|
Gastropem
|
40 mg
|
Enteric-Coated Tablet
|
-
|
Sunrise International Labs Limited
|
India
|
Initial
|
10 May 2023
|
10 May 2028
|
| View |
|
DRP-13882
|
Clobetasol propionate
|
None
|
500 mcg/g (0.05% w/w)
|
Topical Cream
|
-
|
Agio Pharmaceuticals Ltd.
|
India
|
Initial
|
11 May 2023
|
11 May 2028
|
| View |
|
DR-XY48725
|
Ezetimibe + Simvastatin
|
Vytocor
|
10 mg/40 mg
|
Tablet
|
-
|
Duopharma (M) Sdn. Bhd.
|
Malaysia
|
Initial
|
11 May 2023
|
11 May 2028
|
| View |
|
DR-XY48724
|
Bortezomib
|
None
|
3.5 mg
|
Lyophilized Powder for Solution for Injection. (I.V./S.C.)
|
-
|
Venus Remedies Limited
|
India
|
Initial
|
11 May 2023
|
11 May 2028
|
| View |
|
DR-XY48726
|
Amino acids + Electrolytes + Glucose
|
Aminomix Peripheral
|
Formulation (after homogenous mixture of the contents of the 2-chamber bag):
Each 1 L of solution
contains:
L-Threonine 1.54 g
L-Alanine 4.90 g
L-Tryptophan 700 mg
L-Arginine 4.20 g
L-Tyrosine 140 mg
L-Valine 2.17 g
Glycine 3.85 g
L-Histidine 1.05 g
Calcium chloride (as dihydrate)
180 mg
L-Isoleucine 1.75 g
Sodium glycerophosphate (as hydrated)
1.78 g
L-Leucine 2.59 g
L-Lysine (as acetate) 2.31 g
Magnesium sulfate (as heptahydrate)
380 mg
L-Methionine 1.51 g
Potassium chloride 1.41 g
L-Phenylalanine 1.79 g
Sodium acetate (as trihydrate) 700 mg
Glucose (as monohydrate) 63 g
L-Proline 3.92 g
Water for injection, q.s. IL
L-Serine 2.28 g
Taurine
350 mg
|
Solution For I.V. Infusion
|
-
|
Fresenius Kabi Austria GmbH
|
Austria
|
Initial
|
11 May 2023
|
11 May 2028
|
| View |
|
DRP-13891
|
Co-Amoxiclav
|
Maxclav 1.2
|
1.2 g
|
Powder For Injection (IV)
|
-
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
11 May 2023
|
11 May 2028
|