| View |
|
DR-XY49034
|
Rivaroxaban
|
Verxaban
|
15 mg
|
Film-Coated Tablet
|
Antithrombotic Agent (Direct factor Xa inhibitor)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
04 April 2024
|
04 April 2029
|
| View |
|
DRP-15071
|
Tobramycin (as sulfate) + Dexamethasone
|
Tobramet
|
3 mg/1 mg per mL (0.3% /0.1% w/v)
|
Ophthalmic
Suspension
|
Antibacterial and Corticosteroid
|
Indiana Ophthalmics
|
India
|
Initial
|
04 April 2024
|
04 April 2029
|
| View |
|
BR-1480
|
Spesolimab
|
Spevigo
|
450 mg/7.5 mL (60 mg/mL)
|
Concentrate for Solution for
Infusion (IV)
|
Interleukin inhibitors
|
Boehringer Ingelheim Pharma GmbH & Co. KG
|
Germany
|
Monitored Release (MR)
|
05 April 2024
|
05 April 2029
|
| View |
|
DRP-15022
|
Mupirocin
|
Mupisur
|
20 mg/g (2% w/w)
|
Cream
|
Antibacterial
|
Kwality Pharmaceuticals Limited
|
India
|
Initial [OTC]
|
04 April 2024
|
04 April 2029
|
| View |
|
DRP-15067
|
Hydroxychoroquine Sulfate
|
H-Klor
|
200mg
|
Film-Coated Tablet
|
Antimalarial (Aminoquinolines)
|
Bafna Pharmaceuticals Limited
|
India
|
Initial
|
08 April 2024
|
08 April 2029
|
| View |
|
DRP-10604-05
|
Levodropropizine
|
Pecof Dry
|
30 mg/5 mL
|
Syrup
|
Cough Suppressant
|
Lloyd Laboratories, Inc.
|
Philippines
|
CLIDP Conversion
|
29 May 2023
|
22 October 2026
|
| View |
|
DRP-10604-04
|
Levodropropizine
|
Levopres
|
30 mg/5 mL
|
Syrup
|
Cough Suppressant
|
Lloyd Laboratories, Inc.
|
Philippines
|
CLIDP Conversion
|
26 April 2023
|
22 October 2026
|
| View |
|
DRP-10604-02
|
Levodropropizine
|
Rapifort
|
30 mg/5 mL
|
Syrup
|
Cough Suppressant
|
Lloyd Laboratories, Inc
|
Philippines
|
CLIDP Conversion
|
09 February 2023
|
22 October 2026
|
| View |
|
DRP-10604-03
|
Levodropropizine
|
Peritus
|
30 mg/5 mL
|
Syrup
|
Cough Suppressant
|
Lloyd Laboratories, Inc
|
Philippines
|
CLIDP Conversion
|
11 February 2023
|
22 October 2026
|
| View |
|
DRP-15072
|
Ofloxacin
|
Ofloxasaph-INF
|
2 mg/mL (200 mg/100 mL)
|
Solution for Intravenous
Infusion
|
Antibacterial (Fluoroquinolone)
|
Althea Pharma Pvt. Ltd.
|
India
|
Initial
|
12 April 2024
|
12 April 2029
|
| View |
|
DRP-15074
|
Norepinephrine (as bitartrate)
|
Norepin 16
|
1 mg/mL (16 mg/16 mL)
|
Concentrate Solution. for IV Infusion
|
Adrenergic Agent
|
United Biotech Pvt. Ltd.
|
India
|
Initial
|
12 April 2024
|
12 April 2029
|
| View |
|
DRP-15073
|
Methotrexate
|
Trexglo
|
2.5 mg
|
Tablet
|
Antineoplastic
|
Globela Pharma Private Limited
|
India
|
Initial
|
12 April 2024
|
12 April 2029
|
| View |
|
DR-XY49050
|
Pantoprazole (as sodium)
|
Panzel
|
40 mg
|
Enteric-Coated Tablet
|
Proton Pump Inhibitor
|
Zee Laboratories.
|
India
|
Initial
|
17 April 2024
|
17 April 2029
|
| View |
|
DRP-14253
|
Domperidone
|
Abdopen
|
10 mg
|
Film-Coated Tablet
|
Propulsive
|
Centurion Laboratories Pvt. Ltd.
|
India
|
Initial [OTC]
|
17 April 2024
|
17 April 2029
|
| View |
|
DRP-15039
|
Sitagliptin (as phosphate) + Metformin Hydrochloride.
|
KoztaTM Plus
|
50 mg/850 mg
|
Film-Coated Tablet
|
Antidiabetic Agent [Dipeptidyl peptidase 4 (DPP-4)
Inhibitor/Biguanide]
|
Intas Pharmaceuticals Limited
|
India
|
Initial
|
17 April 2024
|
17 April 2029
|
| View |
|
DRP-14251
|
Hydrocortisone + Bacitracin + Polymyxin B Sulfate +
Neomycin
|
Saphcorticin
|
10 mg/ 200 IU/4000 IU/3 mg per g
|
Topical Ointment
|
Antibacterial / Corticosteroid
|
Azine Healthcare Pvt. Ltd
|
India
|
Initial
|
17 April 2024
|
17 April 2029
|
| View |
|
DR-XY49044
|
Hydroxyethyl Starch 200/0.5 Sodium Chloride.
|
HES-200
|
30 g/ 4.5 g (200/0.5) per 500 mL
|
Solution for Injection
(IV)
|
Blood Substitute and Plasma Protein Fractions
|
Shandong Qidu Pharmaceutical Co., Ltd.
|
China
|
Initial (Correction)
|
21 May 2024
|
16 April 2029
|
| View |
|
DR-XY49045
|
Hydroxyethyl Starch 130/0.4+ Sodium Chloride
|
HES-130
|
30 g/ 4.5 g (130/0.4) per 500 mL
|
Solution for Injection.
(IV)
|
Blood Substitute and Plasma Protein Fractions
|
Shandong Qidu Pharmaceutical Co., Ltd.
|
China
|
Initial (Correction)
|
28 June 2024
|
16 April 2029
|
| View |
|
DR-XY49046
|
Hydroxyethyl Starch 130/0.4+ Sodium Chloride
|
HES-130
|
15 g/ 2.25 g (130/0.4) per 250 mL
|
Solution for Injection (IV)
|
Blood Substitute and Plasma Protein Fractions
|
Shandong Qidu Pharmaceutical Co., Ltd.
|
China
|
Initial (Correction)
|
21 May 2024
|
16 April 2029
|
| View |
|
DR-XY49038
|
Valsartan + Amlodipine (as besylate) +
Hydrochlorothiazide
|
Valcare AH 160/5/12.5
|
160 mg/ 5 mg/ 12.5 mg
|
Film-Coated Tablet.
|
Angiotensin II Receptor Blocker (ARB), Other
Combinations
|
Macleods Pharmaceuticals Limited
|
India
|
Initial
|
16 April 2024
|
16 April 2029
|