| View |
|
DRP-13853
|
Ampicillin (as sodium)
|
Ampisaph-1000
|
1 g
|
Powder For Injection (IM/IV)
|
-
|
Bueno Salud Care (India) Pvt. Ltd.
|
India
|
Initial
|
03 May 2023
|
03 May 2028
|
| View |
DRP-13854_PI_01.pdf
|
DRP-13854
|
Sitagliptin (as phosphate monohydrate)
|
Taglisyd
|
100 mg
|
Film-Coated Tablet
|
-
|
Sydenham Laboratories, Inc.
|
Philippines
|
Initial
|
03 May 2023
|
03 May 2028
|
| View |
|
DRP-13855
|
Etoricoxib
|
Orixa
|
60 mg
|
Film-Coated Tablet
|
-
|
PT Dexa Medica
|
Indonesia
|
Initial
|
03 May 2023
|
03 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 |
|
DRP-13872
|
Salbutamol (as sulfate)
|
Salbusaph
|
2 mg/5 mL
|
Syrup
|
-
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
09 May 2023
|
09 May 2028
|
| View |
|
DRP-13862
|
Paracetamol
|
Feverbles
|
150 mg/ mL
|
Solution for Injection (IM/IV)
|
-
|
Makcur Laboratories Limited
|
India
|
Initial
|
04 May 2023
|
04 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 |
|
DRP-13861
|
Thiamine (Vitamin B1)+ Pyridoxine (Vitamin B6) + Cyanocobalamin (Vitamin B12)
|
None
|
100 mg/100 mg/1 mg
|
Solution for Injection (IM)
|
-
|
Reyoung Pharmaceutical Co., Ltd..
|
China
|
Initial
|
04 May 2023
|
04 May 2028
|
| View |
|
DRP-13868
|
Metformin Hydrochloride
|
Glumet-XR
|
1 g
|
Prolonged-Release Tablet
|
-
|
Inventia Healthcare Limited
|
India
|
Initial
|
05 May 2023
|
05 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 |
|
DRP-13849
|
Sildenafil (as citrate)
|
None
|
100 mg
|
Film Coated Tablet
|
-
|
Diamond Laboratories Inc.
|
Philippines
|
Initial
|
02 May 2023
|
02 May 2028
|
| View |
|
DRP-13859
|
Sitagliptin (as phosphate)
|
Instadip 25
|
25 mg
|
Film-Coated Tablet
|
Dipeptidyl Peptidase 4 (DPP-4) Inhibitor
|
Sun Pharmaceutical Industries Limited
|
India
|
Initial (Correction)
|
18 April 2024
|
11 May 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-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 |
|
DRP-13860
|
Miconazole (as nitrate)
|
Saphmicon
|
20 mg/g (2% w/w)
|
Topical Cream
|
Antifungal
|
Bueno Salud Care (India) Pvt. Ltd.
|
India
|
Initial (Correction)
|
30 January 2024
|
04 May 2028
|
| View |
|
DRP-13867
|
Levetiracetam
|
Masolev
|
100 mg/mL (500 mg/5 mL)
|
Solution for Injection (I.V.)
|
-
|
Mason Pharma
|
India
|
Initial
|
05 May 2023
|
05 May 2028
|
| View |
|
DRP-13834
|
Citicoline (as sodium)
|
Citisaph-1000
|
1 g
|
Film-Coated Tablet
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
02 May 2023
|
02 May 2028
|
| View |
|
DRP-13850
|
Dexketoprofen (as Trometamol)
|
Dexproken
|
25 mg/mL (50 mg/2 mL)
|
Solution For Injection (IM/IV)
|
-
|
İdol İlaç Dolum San. Ve Tic. A.Ş.
|
Turkey
|
Initial
|
05 May 2023
|
05 May 2028
|
| View |
|
DRP-13857
|
Ascorbic Acid + Zinc
|
Medifortan-C Plus Zinc
|
500 mg (equivalent to 562.4 mg Sodium Ascorbate) /
12.5 mg (equivalent to 34.31 mg Zinc Sulfate
Monohydrate)
|
Capsule
|
-
|
Medi-Rx, Inc.
|
Philippines
|
Initial
|
03 May 2023
|
03 May 2028
|