| View |
|
DR-XY49087
|
Ivabradine (as hydrochloride)
|
Abrin
|
7.5 mg
|
Film-Coated Tablet
|
Other Cardiac Preparation.
|
The Searle Company Limited
|
Pakistan
|
Initial (Reapplication)
|
21 May 2024
|
21 May 2029
|
| View |
|
DRP-15177
|
Amlodipine (as besylate) + Atorvastatin (as calcium)
|
Amlotin
|
5 mg/10 mg
|
Film-Coated Tablet
|
Lipid Modifying Agent in Combination with Other Drug
|
Novagen Healthcare Private Limited
|
India
|
Initial
|
21 May 2024
|
21 May 2029
|
| View |
|
DRP-15178
|
Amlodipine (as besylate) + Atorvastatin (as calcium)
|
Amlotin
|
5 mg/ 20 mg
|
Film-Coated Tablet
|
Lipid Modifying Agent in Combination with Other Drug
|
Novagen Healthcare Private Limited.
|
India
|
Initial
|
21 May 2024
|
21 May 2029
|
| View |
|
DRP-15179
|
Amlodipine (as besylate) + Atorvastatin (as calcium)
|
Amlotin
|
10 mg/ 10 mg
|
Film-Coated Tablet
|
Lipid Modifying Agent in Combination with Other Drug
|
Novagen Healthcare Private Limited
|
India
|
Initial
|
21 May 2024
|
21 May 2029
|
| View |
|
BR-1483
|
Meningococcal group B Vaccine (rDNA, component,
adsorbed)
|
Bexsero
|
Formulation:
One dose (0.5 mL) contains:
Recombinant Neisseria meningitidis group B NHBA fusion protein1.2.3 -50 mcg Recombinant Neisseria meningitidis-group B NadA protein1.2.3- 50 mcg
Recombinant Neisseria meningitidis group B fHbp fusion protein1.2.3 -50 mcg
Outer membrane vesicles (OMV) from Neisseria meningitidis group B strain 25 mcg
NZ98/254 measured as amount of total protein containing the PorA P1.42
produced in E. coli cells by recombinant DNA technology
2Adsorbed on Aluminum hydroxide (0.5 mg Al1)
'NHBA (Neisseria Heparin Binding Antigen), NadA (Neisseria adhesin A). (Hbp
(factor H binding protein)
|
Suspension for Injection (IM)
|
Meningococcal Vaccines
|
GlaxoSmithKline Vaccines S.r.1
|
Italy
|
Monitored Release (MR)
|
21 May 2024
|
21 May 2029
|
| View |
|
DR-XY44446
|
Cefepime (as hydrochloride) + Tazobactam (as sodium)
|
Saptaz
|
1 g/125 mg
|
Powder for Injection (IM/IV)
|
Antibacterial (Beta-lactamase inhibitor)
|
Makcur Laboratories Ltd.
|
India
|
Renewal
|
25 March 2022
|
17 April 2025
|
| View |
|
DRP-6050-02
|
Rabeprazole Sodium
|
Ziomedrab
|
20 mg
|
Lyophilized Powder For Injection (IV)
|
Proton Pump Inhibitor
|
Endurance Healthcare Ltd.
|
India
|
Initial (Correction)
|
07 June 2021
|
25 March 2025
|
| View |
|
DRP-11162-04
|
Piperacillin (as sodium) + Tazobactam (as sodium)
|
Gobapizin
|
4g/500 mg
|
Powder for Injection (I.V)
|
Antibacterial (Penicillin-Beta-Lactamase Inhibitor Combination)
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
CLIDP Conversion
|
20 May 2024
|
08 February 2027
|
| View |
|
DRP-11636-03
|
Amlodipine (as besilate)
|
Vasconov
|
10 mg
|
Tablet
|
Calcium Channel Blocker
|
Ratnatris Pharmaceuticals Pvt. Ltd.
|
India
|
CLIDP Conversion
|
21 May 2024
|
04 April 2027
|
| View |
|
DRP-11935-01
|
Anastrozole
|
Anazdex
|
1 mg
|
Film-Coated Tablet
|
Aromatase Inhibitor
|
Kwang Dong Pharmaceutical Co., Ltd.
|
Korea
|
CLIDP Conversion
|
18 May 2024
|
20 May 2027
|
| View |
|
DRP-12144-02
|
Amlodipine (as besilate)
|
None
|
5 mg
|
Tablet
|
Calcium Channel Blocker
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
CLIDP Conversion
|
21 May 2024
|
22 June 2027
|
| View |
|
DRP-12192-03
|
Co-Amoxiclav
|
None
|
457 mg/5 mL
|
Powder for Oral Suspension
|
Antibacterial (Penicillin)
|
J.M. Tolmann Laboratories, Inc.
|
Philippines
|
CLIDP Conversion
|
20 May 2024
|
02 September 2027
|
| View |
|
DRP-12600-06
|
Febuxostat
|
Fixuric 80
|
80 mg
|
Film-Coated Tablet
|
Antigout
|
Sunrise International Labs Limited
|
India
|
CLIDP Conversion
|
19 May 2024
|
14 September 2027
|
| View |
|
DRP-12622-08
|
Montelukast (as sodium)+ Levocetirizine Hydrochloride
|
Alasth
|
10mg/5mg
|
Film-Coated Tablet
|
Leukotriene Receptor Antagonist/ Antihistamine
|
Magbro Healthcare Pvt. Ltd
|
India
|
CLIDP Conversion
|
19 May 2024
|
29 June 2027
|
| View |
|
DRP-13127-09
|
Ketoanalogues + Essential Amino Acids
|
Ketoace
|
(See reverse for formulation)
|
Film-Coated Tablet
|
Renal Nutrition Therapy
|
Magbro Healthcare Pvt. Ltd.
|
India
|
CLIDP Conversion
|
22 May 2024
|
05 December 2027
|
| View |
|
DRP-13149-02
|
Ascorbic Acid + Zinc
|
Medic-Z
|
500 mg (equivalent to 562.43 mg Sodium Ascorbate) / 10 mg (27.5 mg Zinc Sulfate Monohydrate)
|
Capsule
|
Vitamin /Mineral
|
St. Martin Pharm Lab Co.
|
Philippines
|
CLIDP Conversion
|
21 May 2024
|
12 December 2027
|
| View |
|
DRP-13209-03
|
Pregabalin
|
Gobeiz
|
75 mg
|
Capsule
|
Antiepileptic
|
Titan Laboratories Pvt. Ltd.
|
India
|
CLIDP Conversion
|
22 May 2024
|
29 December 2027
|
| View |
|
DRP-13237-07
|
Ursodeoxycholic Acid
|
None
|
500 mg
|
Film-Coated Tablet
|
Bile Acid and Derivative
|
Magbro Healthcare Pvt. Ltd
|
India
|
CLIDP Conversion
|
21 May 2024
|
06 January 2028
|
| View |
|
DRP-13391-04
|
Bleomycin (as Sulfate)
|
Bleophil
|
15 Units
|
Powder for Solution for Injection (IM/IV/SC)
|
Antineoplastic Agent
|
Venus Remedies Limited
|
India
|
CLIDP Conversion
|
20 May 2024
|
16 February 2028
|
| View |
|
DRP-13514-01
|
Omeprazole (as sodium)
|
Zypant
|
40 mg
|
Lyophilized Powder for Injection (IV)
|
Proton Pump Inhibitor
|
Nitin Lifesciences Ltd. (Unit III)
|
India
|
CLIDP Conversion
|
20 May 2024
|
02 March 2028
|