| View |
|
DR-XY48711
|
Clobetasol propionate
|
Clobetor
|
500 mcg/g
|
Ointment
|
-
|
Torrent Pharmaceuticals Limited
|
India
|
Initial
|
26 April 2023
|
26 April 2028
|
| View |
|
DR-XY48712
|
Empagliflozin
|
Jardiance
|
25mg
|
Film-Coated Tablet
|
-
|
Rottendorf Pharma GmbH
|
Germany
|
Initial (Variation)
|
03 January 2024
|
03 January 2029
|
| View |
|
DR-XY48713
|
Empagliflozin
|
Jardiance
|
10mg
|
Film-Coated Tablet
|
-
|
Rottendorf Pharma GmbH
|
Germany
|
Initial (Variation)
|
03 January 2024
|
03 January 2029
|
| View |
|
DR-XY48714
|
Gadoteric Acid
|
Clariscan
|
0.5 mmol/mL (equivalent to 279.32 mg/mL)
|
Solution for Injection (I.V.)
|
-
|
GE Healthcare AS - Oslo Plant
|
Norway
|
Initial
|
28 April 2023
|
28 April 2028
|
| View |
|
DR-XY48715
|
Azacitidine
|
None
|
100 mg
|
Lyophilized Powder for Injection (IV/SC)
|
-
|
Shilpa Medicare Limited (Unit-4, Pharmaceutical
Formulations SEZ)
|
India
|
Monitored Release
|
28 April 2023
|
28 April 2028
|
| View |
|
DR-XY48717
|
Clotrimazole
|
Dermivex
|
1% w/w
|
Cream
|
-
|
Yash Pharmaceuticals
|
India
|
Initial
|
19 May 2023
|
19 May 2028
|
| View |
|
DR-XY48718
|
0.9% Sodium Chloride
|
None
|
900 mg/100 mL (0.9% w/v)
|
Solution for IV Infusion
|
-
|
Fresenius Kabi India Pvt. Ltd.
|
India
|
Initial
|
04 May 2023
|
04 May 2028
|
| View |
|
DR-XY48719
|
Cholecalciferol (Vitamin D3)
|
None
|
5,000 IU
|
Softgel Capsule
|
-
|
Now Foods
|
U.S.A
|
Initial [OTC]
|
04 May 2023
|
04 May 2028
|
| View |
|
DR-XY48720
|
Amoxicillin (as trihydrate)
|
Spamox
|
500 mg
|
Capsule
|
Antibacterial (Penicillin)
|
Sparsh Bio-Tech Pvt. Ltd.
|
India
|
Initial
|
08 May 2023
|
08 May 2028
|
| View |
|
DR-XY48721
|
Docetaxel
|
None
|
20 mg/mL
|
Concentrate Solution for I.V. Infusion
|
-
|
Venus Remedies Limited
|
India
|
Initial
|
08 May 2023
|
08 May 2028
|
| View |
|
DR-XY48722
|
Mupirocin
|
Muprivex
|
20MG/G (2% w/w)
|
Ointment
|
Antibacterial (Antibiotic for Topical Use)
|
Yash Pharmaceuticals
|
India
|
Initial (OTC) Correction]
|
02 February 2024
|
26 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 |
|
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-XY48725
|
Ezetimibe + Simvastatin
|
Vytocor
|
10 mg/40 mg
|
Tablet
|
-
|
Duopharma (M) Sdn. Bhd.
|
Malaysia
|
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 |
|
DR-XY48727
|
Febuxostat
|
Fegout
|
40 mg
|
Film-Coated Tablet
|
-
|
Koera United Pharm. Inc.
|
Korea
|
Initial
|
15 May 2023
|
15 May 2028
|
| View |
|
DR-XY48728
|
Piperacillin as (sodium) + Tazobactam (as sodium)
|
PZBactam
|
2 g/250
|
Powder For Injection
|
-
|
Zee Laboratories Limited
|
India
|
Initial
|
17 May 2023
|
17 May 2028
|
| View |
|
DR-XY48729
|
Etoricoxib
|
Etoroxx
|
120mg
|
Film-Coated Tablet
|
-
|
Ajanta Pharma Limited
|
India
|
Initial
|
18 May 2023
|
18 May 2028
|
| View |
|
DR-XY48730
|
Etoricoxib
|
Etoroxx
|
90mg
|
Film-Coated Tablet
|
-
|
Ajanta Pharma Limited
|
India
|
Initial
|
18 May 2023
|
18 May 2028
|
| View |
|
DR-XY48731
|
Etoricoxib
|
Etoroxx
|
60mg
|
Film-Coated Tablet
|
-
|
Ajanta Pharma Limited
|
India
|
Initial
|
18 May 2023
|
18 May 2028
|