View |
|
DRP-5052-18
|
Cefixime (as trihydrate)
|
Cefigen
|
100 mg/5mL
|
Granules for Suspension
|
Antibacterial (Third Generation Cephalosporin)
|
J.M. Tolmann Laboratories, Inc.
|
Philippines
|
Initial (Variation)
|
23 May 2024
|
18 August 2027
|
View |
|
DRP-15193
|
Pantoprazole (as sodium sesquihydrate) + Domperidone
|
Panglo DSR
|
40 mg/30 mg
|
Modified Release Capsule
|
Proton Pump Inhibitor/Prokinetic
|
Globela Pharma Private Limited
|
India
|
Initial
|
24 May 2024
|
24 May 2029
|
View |
|
BRP-139
|
Diphtheria and Tetanus Vaccine (Adsorbed)
|
None
|
Formulation:
Each dose (0.5 mL) contains:
Diphtheria Toxoid- 2 Lf (30 IU)
Tetanus Toxoid-7.5 Lf (40 IU)
Aluminum phosphate*-1.5 mg
Thiomersal*-0.05 mg
|
Suspension For Injection (IM)
|
Biologicals/ Vaccines
|
PT. Biofarma (Persero)
|
Indonesia
|
Initial
|
27 May 2024
|
27 May 2029
|
View |
|
DRP-15197
|
Vancomycin (as Hydrochloride)
|
Vaxcicin
|
500 mg
|
Powder For Injection
|
Glycopeptide Antibacterial
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
27 May 2024
|
27 May 2029
|
View |
|
DRP-15196
|
Vancomycin (as Hydrochloride)
|
Vaxcicin
|
1 g
|
Powder For Injection
|
Glycopeptide Antibacterial
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
27 May 2024
|
27 May 2029
|
View |
|
DR-XY49095
|
Ceftriaxone (as sodium)
|
Luoriaxon
|
1 g
|
Powder for Solution for Injection (IM/IV)/Infusion
|
Third-Generation Cephalosporin
|
Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.
|
China
|
Initial
|
27 May 2024
|
27 May 2029
|
View |
|
DR-XY49094
|
Ceftriaxone
|
Luotriaxone
|
500 mg
|
Powder for Solution for Injection (IM/IV)/
Infusion
|
Third-Generation Cephalosporin
|
Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.
|
China
|
Initial
|
27 May 2024
|
27 May 2029
|
View |
|
DRP-15206
|
Paracetamol
|
Sanpara
|
500 mg
|
Tablet
|
Analgesic/Antipyretic
|
Pell Tech Heatlh Care Private Ltd.
|
India
|
Initial [OTC]
|
27 May 2024
|
27 May 2029
|
View |
|
THPRP-009
|
Pelargonium sidoides DC. Root
|
None
|
20 mg/5 mL
|
Syrup
|
For symptomatic treatment of the common cold
|
Pascual Laboratories, Inc.
|
Philippines
|
Initial
|
28 May 2024
|
28 May 2029
|
View |
|
DRP-15208
|
Lysozyme Hydrochloride
|
Lynase
|
0.5mg/ mL
|
Nasal Spray Solution
|
Decongestant
|
Bosnalijek D.D.
|
Bosnia and Herzegovina
|
Initial
|
28 May 2024
|
28 May 2029
|
View |
|
DRP-15207
|
Paracetamol
|
Nortemp
|
500 mg
|
Tablet
|
Analgesic / Antipyretic
|
Pharma Technica Laboratory, Inc.
|
Philippines
|
Initial
|
28 May 2024
|
28 May 2029
|
View |
|
DRP-15209
|
Chlorhexidine Gluconate
|
HexiMed
|
1.2 mg/mL (0.12% w/v)
|
Oral Rinse Solution
|
Oral Antiseptic
|
Kohl Industries Corporation
|
Philippines
|
Initial
|
28 May 2024
|
28 May 2026
|
View |
|
DR-XY49096
|
Loperamide + Simethicone
|
Imodium Complete Relief
|
2 mg/125 mg
|
Tablet
|
Antipropulsive
|
JNTL Consumer Health (France) S.A.S.
|
France
|
Initial
|
28 May 2024
|
28 May 2029
|
View |
|
DRMO-109
|
Medical Grade Oxygen
|
None
|
None
|
None
|
Medical Gas
|
Pryce Gases, Inc.
|
Philippines
|
Initial
|
28 May 2024
|
28 May 2029
|
View |
|
DR-XY47673
|
Letrozole
|
Brezole
|
2.5mg
|
Film-Coated Tablet
|
Antineoplastic (Aromatase Inhibitor)
|
|
|
Initial (Variation)
|
10 November 2022
|
25 January 2027
|
View |
|
DRP-11805-01
|
Co-Amoxiclav
|
Giclav
|
625 mg
|
Film-Coated Tablet
|
Antibacterial (Penicillin/Beta-lactamase Inhibitor)
|
Yeluri Formulations Pvt. Ltd
|
India
|
CLIDP Conversion
|
11 August 2023
|
05 May 2027
|
View |
|
DRP-11805-03
|
Co-Amoxiclav
|
Cassaclav
|
625 mg
|
Film-Coated Tablet
|
Antibacterial (Penicillin/Beta-lactamase Inhibitor)
|
Yeluri Formulations Pvt. Ltd
|
India
|
CLIDP Conversion
|
28 November 2022
|
05 May 2027
|
View |
|
DRP-11461-02
|
Febuxostat
|
Retaxostat
|
80 mg
|
Film-Coated Tablet
|
Antigout
|
Acme Formulation Pvt. Ltd.
|
India
|
CLIDP Conversion
|
13 February 2023
|
15 March 2027
|
View |
|
DRP-11401-04
|
Capecitabine
|
Gencitav
|
500 mg
|
Film-Coated Tablet
|
Antineoplastic (Pyrimidine Analogue)
|
Laboratorio Eczane Pharma S.A
|
Argentine Republic
|
CLIDP Conversion
|
02 March 2023
|
09 March 2027
|
View |
|
DRP-12596-01
|
Oxaliplatin
|
Genplatin
|
100 mg
|
Lyophilized Powder for Injection (IV Infusion)
|
Antineoplastic Agent (Platinum Compound)
|
Chong Kun Dang Pharmaceutical Corp.
|
Korea
|
CLIDP Conversion
|
07 March 2023
|
12 September 2027
|