| View |
|
DRP-15147
|
Levofloxacin (as hemihydrate)
|
Televo
|
500 mg
|
Film-Coated Tablet
|
Antibacterial (Fluoroquinolone)
|
PSA Chemicals & Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
14 May 2024
|
14 May 2029
|
| View |
|
DRP-15148
|
Cefepime (as hydrochloride)
|
Mofixem
|
1 g
|
Powder for Injection (I.M./I.V.)
|
Antibacterial (Cephalosporin)
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
14 May 2024
|
14 May 2029
|
| View |
|
DRP-15149
|
Ceftriaxone (as sodium)
|
Triacef
|
1 g
|
Powder for Injection (I.M./I.V.)
|
Antibacterial (Cephalosporin)
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
14 May 2024
|
14 May 2029
|
| View |
|
DRP-15156
|
Losartan potassium
|
Prestan
|
50 mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker
|
Hizon Laboratories, Inc.
|
Philippines
|
Initial (Reapplication)
|
15 May 2024
|
15 May 2029
|
| View |
|
DRP-15141
|
Bromocriptine (as mesilate)
|
Brocriptex
|
2.5 mg
|
Tablet
|
Dopamine Agonist
|
Par Laboratories
|
India
|
Initial
|
15 May 2024
|
15 May 2027
|
| View |
|
DRP-15153
|
Monobasic Sodium Phosphate + Dibasic Sodium Phosphate
|
Lainema
|
13.9 g/3.2 g per 100 mL
|
Rectal Solution
|
Laxative
|
Lainco, SA
|
Spain
|
Initial [OTC]
|
15 May 2024
|
15 May 2029
|
| View |
|
DRP-15152
|
Paracetamol
|
Parol
|
500 mg
|
Tablet
|
Analgesic/Antipyretic
|
Atabay Ilac Fabrikasi A.S.
|
Turkey
|
Initial [OTC]
|
15 May 2024
|
15 May 2029
|
| View |
|
DR-XY49082
|
Lidocaine hydrochloride + Epinephrine.
|
Crysta FD
|
20 mg/10 mcg per mL
|
Solution for Injection (Local
Infiltration)
|
Local Anesthetic
|
Laboratorios Zeyco S.A. De C.V.
|
Mexico
|
Initial
|
14 May 2024
|
14 May 2029
|
| View |
|
DRP-15151
|
Ascorbic Acid + Zinc
|
AZCORVIT
|
500mg (equivalent to 562.42 mg Sodium Ascorbate)/10 mg (equivalent to 27.50 mg Zinc Sulfate Monohydrate)
|
Capsule
|
Vitamin/Mineral
|
AM-Europharma Corporation
|
Philippines
|
Initial [OTC][PCPR](Correction)
|
15 May 2024
|
11 March 2026
|
| View |
|
DRP-15160
|
Levothyroxine Sodium
|
Euthyrox
|
100 mcg
|
Tablet
|
Thyroid Hormone Replacement
|
Merck Healthcare KGAA
|
Germany
|
Initial(Re-issuance)
|
16 May 2024
|
17 November 2026
|
| View |
|
DRP-15158
|
Levocarnitine
|
Metacartin
|
1g/ 10mL
|
Oral Solution
|
Amino Acid and derivative
|
World Medicine Ilac Sanayi Ve Ticaret A.S.
|
Turkey
|
Initial (Re-issuance)
|
16 May 2024
|
02 July 2025
|
| View |
|
DR-XY49085
|
Ceftriaxone (as sodium)
|
Trixophin-W
|
1 g
|
Sterile Powder for Solution for Injection (IM/IV)
|
Third-Generation Cephalosporin
|
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
|
China
|
Initial
|
17 May 2024
|
17 May 2029
|
| View |
|
DR-XY49075
|
Ursodeoxycholic Acid
|
Ursoliv 500
|
500 mg
|
Film-Coated Tablet
|
Bile and Liver Therapy (Bile acids and derivative)
|
Mega Lifesciences Public Company Limited
|
Thailand
|
Initial (Correction)
|
31 July 2024
|
19 September 2027
|
| View |
|
DR-XY49086
|
Caspofungin (as acetate)
|
Fungitame 70
|
70 mg
|
Lyophilized Powder for Concentrated Solution for
IV Infusion
|
Other Antimycotic for Systemic Use
|
Pharmaten SA
|
Greece
|
Initial
|
20 May 2024
|
20 May 2029
|
| View |
|
DRP-15180
|
Cefuroxime (as sodium)
|
Sinbact 750
|
750 mg
|
Powder for Injection (IM/IV)
|
Antibacterial (Second-generation cephalosporin)
|
Makcur Laboratories Limited
|
India
|
Initial
|
21 May 2024
|
21 May 2029
|
| View |
|
DRP-15184
|
Dutasteride
|
Dutaprost
|
500 mcg
|
Softgel Capsule
|
Testosterone-5-alpha Reductase Inhibitor
|
Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd.
|
China
|
Initial
|
21 May 2024
|
21 May 2029
|
| View |
|
DRP-15181
|
Co-amoxiclav
|
Klaviran DS
|
156.25 mg per 5 mL FORMULATION:
Each 5 mL contains:
Amoxicillin (as trihydrate) 125 mg equivalent to 131.25 mg
Clavulanic Acid (as potassium clavulanate) 31.25 mg equivalent to 33.75 mg
|
Powder for Oral Suspension
|
Antibacterial (Penicillin/Beta-lactam inhibitor)
|
Giyaan Pharma Private Limited
|
India
|
Initial
|
21 May 2024
|
21 May 2029
|
| View |
|
DRP-15183
|
Co-Amoxiclav
|
Klaviran
|
1g
|
Film-Coated Tablet
|
Antibacterial (Penicillin/Beta-lactamase Inhibitor)
|
Giyaan Pharma Private Limited.
|
India
|
Initial
|
21 May 2024
|
21 May 2029
|
| View |
|
DRP-15185
|
Sterile Water for Injection
|
None
|
10 mL
|
Solution for Injection
|
Diluent/Solvent for Parenteral Preparation
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
21 May 2024
|
21 May 2029
|
| View |
|
DRP-15182
|
Fenofibrate
|
Fenorix
|
200 mg
|
Micronized Capsule
|
Lipid Modifying Agent (Fibrate)
|
Fredun Pharmaceuticals Limited
|
India
|
Initial
|
21 May 2024
|
21 May 2029
|