| View |
|
DR-XY49048
|
Varenicline (as tartrate)
|
Champix
|
500 mcg
|
Film-Coated Tablet
|
Drugs used in nicotine dependence
|
Pfizer Italia S.r.1.
|
Italy
|
Initial
|
19 April 2024
|
19 April 2029
|
| View |
|
DR-XY49047
|
Varenicline (as tartrate)
|
Champix
|
1 mg
|
Film-Coated Tablet
|
Drugs used in nicotine dependence
|
Pfizer Italia S.r.1.
|
Italy
|
Initial
|
19 April 2024
|
19 April 2029
|
| View |
|
DRP-11948
|
Sitagliptin (as phosphate) + Metformin Hydrochloride
|
Metsaphtin - 50/500
|
50 mg/500 mg
|
Film-Coated Tablet
|
Blood glucose lowering drug (Biguanide/ Dipeptidyl
peptidase 4 [DPP-4] inhibitor)
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
19 April 2024
|
19 April 2029
|
| View |
|
DRP-11947
|
Sitagliptin (as phosphate) + Metformin Hydrochloride.
|
Metsaphtin - 50/850
|
50 mg/850 mg
|
Film-Coated Tablet
|
Blood glucose lowering drug (Biguanide
peptidase 4 [DPP-4] inhibitor)
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
19 April 2024
|
19 April 2029
|
| View |
|
DRP-15090
|
Rabeprazole sodium
|
Rabefaz
|
20 mg
|
Powder for Intravenous Injection.
|
Proton Pump Inhibitor
|
Indasi Lifescience Pvt. Ltd.
|
India
|
Initial
|
19 April 2024
|
19 April 2029
|
| View |
|
DR-XY49057
|
Moxifloxacin (as hydrochloride)
|
Demoxif
|
400 mg
|
Film-Coated Tablet
|
Antibacterial (Fluoroquinolone)
|
Deva Holding A.S.
|
Turkey
|
Initial (Re-application)
|
19 April 2024
|
19 April 2029
|
| View |
|
DRP-8500
|
Cloxacillin (as Sodium)
|
Cloxarex
|
500 mg
|
Powder for Injection (IM/IV)
|
Antibacterial (Penicillin)
|
Jiangxi Xierkantai Pharmaceutical Co., Ltd.
|
China
|
Renewal
|
19 April 2024
|
08 September 2027
|
| View |
|
DRP-13096-2
|
Ketoanalogues + Essential Amino Acids
|
Nepromin
|
630 mg
|
Film-Coated Tablet
|
Renal Nutrition Therapy
|
Magbro Healthcare Pvt. Ltd
|
India
|
CLIDP Conversion
|
24 August 2023
|
01 December 2027
|
| View |
|
DRP-13096-03
|
Ketoanalogues + Essential Amino Acids
|
Renalpro
|
630 mg
|
Film-Coated Tablet
|
Renal Nutrition Therapy
|
Magbro Healthcare Pvt. Ltd.
|
India
|
CLIDP Conversion
|
13 October 2023
|
01 December 2027
|
| View |
|
BR-1393
|
Human Fibrinogen + Human Thrombin
|
TachoSil
|
5.5 mg/2.0 IU per cm2
|
Medicated Sponge
|
Local Hemostatic Agents
|
TAKEDA AUSTRIA GMBH
|
Austria
|
Renewal
|
07 April 2024
|
04 March 2029
|
| View |
|
BRP-124
|
Insulin Human (rDNA)
|
Scilin M30
|
30% Soluble Insulin + 70% Isophane Insulin 100 IU/mL
|
Suspension for Injection (SC)
|
Insulins and Analogues
|
Bioton S.A.
|
Poland
|
Renewal
|
07 April 2024
|
05 April 2029
|
| View |
|
DRP-15092
|
Sevoflurane
|
Sevotroy 250
|
100% v/v
|
Volatile Liquid for Inhalation
|
General Anesthetic
|
Troikaa Pharmaceuticals, Ltd.
|
India
|
CLIDP Conversion
|
27 April 2024
|
14 March 2029
|
| View |
|
DR-XY730
|
Methotrexate
|
Unbranded
|
25 mg/mL (50 mg/2 mL)
|
Solution for Injection (IM/IV/Intrathecal/Intra-arterial)
|
Antineoplastic
|
Hospira Australia Pty. Ltd
|
Australia
|
Renewal
|
25 April 2024
|
08 June 2029
|
| View |
|
DRP-1006-04
|
Co-Amoxiclav
|
None
|
1 g
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Sun Pharmaceuticals Industries LImited
|
India
|
CLIDP Conversion
|
10 April 2024
|
12 August 2028
|
| View |
|
DRP-10246-11
|
Ceftriaxone (as sodium)
|
Alixone
|
1 g
|
Powder for Injection (IM/IV)
|
Antibacterial (Third-Generation Cephalosporin)
|
Theon Pharmaceuticals Limited
|
India
|
CLIDP Conversion
|
28 April 2024
|
01 October 2026
|
| View |
|
DRP-10428-01
|
Cefixime (as trihydrate)
|
Cefugine
|
400 mg
|
Capsule
|
Antibacterial (Cephalosporin)
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
CLIDP Conversion
|
15 April 2024
|
13 October 2026
|
| View |
|
DRP-10429-01
|
Cefixime (as trihydrate)
|
Cefugine
|
200 mg
|
Capsule
|
Antibacterial (Cephalosporin)
|
Azarias Pharmaceutical Laboratories Inc
|
Philippines
|
CLIDP Conversion
|
28 April 2024
|
13 October 2026
|
| View |
|
DRP-10530-06
|
Linezolid
|
Zoditam
|
2mg/mL (600 mg/300 mL)
|
Solution for Injection for IV Infusion
|
Antibacterial (Oxazolidinone)
|
Ahlcon Parenterals (India) Limited
|
India
|
CLIDP Conversion
|
24 April 2024
|
12 October 2026
|
| View |
|
DRP-10637-02
|
Azithromycin (as dihydrate)
|
Rifethromycin
|
500 mg
|
Lyophilized Powder for Injection (I.V.)
|
Antibacterial (Macrolide)
|
Kilitch Drugs (India) Ltd
|
India
|
CLIDP Conversion
|
28 April 2024
|
26 October 2026
|
| View |
|
DRP-10878-07
|
Clopidogrel (as bisuIfate)
|
Clogrix
|
75 mg
|
Film-Coated Tablet
|
Antithrombotic Agent (Platelet Aggregation Inhibitor)
|
Magbro Healthcare Pvt. Ltd
|
India
|
CLIDP Conversion
|
10 April 2024
|
10 December 2026
|