| View |
|
DRP-4948-15
|
Piperacillin (as sodium) + Tazobactam (as sodium)
|
Piperwell
|
4 g /500 mg
|
Powder for Injection (I.M./I.V.)
|
Antibacterial (Penicillin with Beta-lactamase Inhibitor)
|
Inject Care Parenterals Pvt. Ltd.
|
India
|
CLIDP Conversion
|
13 March 2024
|
22 November 2028
|
| View |
|
DRP-15061
|
Rabeprazole sodium
|
Rabazio 20
|
20 mg
|
Enteric-Coated Tablet
|
Proton Pump Inhibitor
|
Agio Pharmaceuticals Ltd.
|
India
|
Initial
|
01 April 2024
|
01 April 2029
|
| View |
|
DR-XY49031
|
Ceftriaxone (as sodium)
|
Ceftrash-1000
|
1 g
|
Powder for Injection (I.M./I.V.)
|
Antibacterial (Third-Generation Cephalosporin)
|
Shamshree Lifesciences Ltd.
|
India
|
Initial
|
01 April 2024
|
01 April 2029
|
| View |
|
DRP-15060
|
Nicardipine hydrochloride
|
Nicardilex
|
1 mg/mL (20 mg/20 mL)
|
Solution for Injection (I.V.)
|
Calcium Channel Blocker (Dihydropyridine Derivative)
|
United Biotech Pvt. Ltd.
|
India
|
Initial
|
01 April 2024
|
01 April 2029
|
| View |
|
DR-XY49001
|
Levonorgestrel
|
Levoplant
|
75 mg
|
Subdermal Implant
|
Hormonal Contraceptive (Progestogen)
|
Shanghai Dahua Pharmaceutical Co., Ltd. 3503
|
China
|
Monitored Release (Re-application)
|
15 March 2024
|
15 March 2029
|
| View |
|
DRP-15066
|
Hydrocortisone (as sodium succinate)
|
Droxisur 100
|
100 mg
|
Powder for Solution for Injection (IM/IV)
|
Corticosteroid
|
Kwality Pharmaceuticals Ltd.
|
India
|
Initial
|
02 April 2024
|
02 April 2029
|
| View |
|
DRP-15064
|
Tobramycin
|
Tobrin
|
3 mg/g (0.3% w/w)
|
Sterile Ophthalmic Ointment.
|
Antibiotic
|
Egyptian International Pharmaceutical Industries Co.
|
Egypt
|
Initial
|
02 April 2024
|
02 April 2029
|
| View |
|
DRP-15062
|
Cefixime (as trihydrate)
|
Lefixime 400
|
400 mg
|
Film-Coated Tablet
|
Antibacterial (Cephalosporin)
|
Innova Captab Ltd.
|
India
|
Initial
|
02 April 2024
|
02 April 2029
|
| View |
|
DRP-15059
|
Tacrolimus (as monohydrate)
|
Cidimus XR
|
5 mg
|
Prolonged-Release Capsule
|
Immunosuppressant (Calcineurin Inhibitor)
|
Lek Pharmaceuticals D.D.
|
Slovenia
|
Initial
|
01 April 2024
|
01 April 2029
|
| View |
|
DRP-15063
|
Cefixime (as trihydrate)
|
Lefixime 200
|
200 mg
|
Film-Coated Tablet
|
Antibacterial (Cephalosporin)
|
Innova Captab Ltd.
|
India
|
Initial
|
02 April 2024
|
02 April 2029
|
| View |
|
DRP-15065
|
Terlipressin (as acetate)
|
Triplessin
|
1 mg/ 10 mL
|
Solution for Injection (I.V.)
|
Vasopressin and Analogues
|
United Biotech Pvt. Ltd.
|
India
|
Initial
|
02 April 2024
|
02 April 2029
|
| View |
|
DRHR-2353
|
Methyl Salicylate + Menthol + Camphor
|
Omega Pain Killer
|
315 mg/ 105 mg /42 mg per gram
|
Cream
|
Counterirritant
|
International Pharmaceuticals, Inc.
|
Philippines
|
Initial
|
04 April 2024
|
04 April 2026
|
| View |
|
DR-XY49032
|
0.9% Sodium Chloride
|
None
|
9 mg/mL (0.9% w/v)
|
Solution for Injection (IV
Infusion)
|
Electrolyte Replenisher
|
Shijiazhuang No. 4 Pharmaceutical Co., Ltd.
|
China
|
Initial
|
02 April 2024
|
02 April 2029
|
| View |
|
DR-XY49033
|
0.9% Sodium Chloride
|
None
|
9 mg/mL (0.9% w/v)
|
Solution for Injection (IV
Infusion)
|
Electrolyte Replenisher
|
Shijiazhuang No. 4 Pharmaceutical Co., Ltd.
|
China
|
Initial
|
02 April 2024
|
02 April 2029
|
| View |
|
DRP-15068
|
Hydroxychloroquine Sulfate
|
None
|
200mg
|
Film-Coated Tablet
|
Antimalarial (Aminoquinolines)
|
Bafna Pharmaceuticals Limited
|
India
|
Initial
|
04 April 2024
|
04 April 2029
|
| View |
|
DR-XY49037
|
Meropenem (as trihydrate)
|
Aemero 500
|
500 mg
|
Powder for Injection (I.V.)
|
Antibacterial (Carbapenem)
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
05 April 2024
|
05 April 2029
|
| View |
|
DR-XY49036
|
Meropenem (as trihydrate)
|
Aemero 1000
|
1 g
|
Powder for Injection (I.V.)
|
Antibacterial (Carbapenem)
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
05 April 2024
|
05 April 2029
|
| View |
|
DRP-15069
|
Levetiracetam
|
Levsezur
|
100 mg/mL
|
Oral Solution
|
Antiepileptic
|
Novagen Healthcare Private Limited
|
India
|
Initial
|
04 April 2024
|
04 April 2029
|
| View |
|
DRP-15070
|
Levetiracetam
|
None
|
100mg/mL
|
Oral Solution
|
Antiepileptic
|
Novagen Healthcare Private Limited
|
India
|
Initial
|
04 April 2024
|
04 April 2029
|
| View |
|
DR-XY49035
|
Rivaroxaban
|
Verxaban
|
10 mg
|
Film-Coated Tablet
|
Antithrombotic Agent (Direct factor Xa inhibitor)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
04 April 2024
|
04 April 2029
|