| View |
|
DRHR-2355
|
Ethyl Alcohol
|
Consumer Protect
|
70 mL per 100 mL (70% v/v)
|
Solution
|
Antiseptic/Disinfectant
|
Destileria Limtuaco & Co., Inc.
|
Philippines
|
Initial
|
07 May 2024
|
07 May 2026
|
| View |
|
DR-XY49073
|
Valproic Acid (as Divalproex sodium)
|
Depakote ER
|
1 g
|
Extended Release Tablet
|
Antiepileptic
|
Abbott Laboratorios Do Brasil LTDA
|
Brazil
|
Monitored Release
|
10 May 2024
|
10 May 2029
|
| View |
|
DRP-15134
|
Losartan Potassium
|
Natrasol 50
|
50 mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker
|
Dagon Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
08 May 2024
|
08 May 2029
|
| View |
|
DRP-15133
|
Losartan Potassium
|
Natrasol 100
|
100 mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker
|
Dagon Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
08 May 2024
|
08 May 2029
|
| View |
|
DR-XY49072
|
Tranexamic Acid.
|
Pause 500
|
500 mg
|
Film-Coated Tablet
|
Antifibrinolytic (Amino Acid)
|
Emcure Pharmaceuticals Ltd.
|
India
|
Initial
|
07 May 2024
|
07 May 2029
|
| View |
|
DRP-15129
|
Carboplatin
|
Neoplin-450
|
10 mg/mL (450 mg/ 45 mL)
|
Solution for Injection (I.V.)
|
Antineoplastic Agent (Platinum Compound)
|
Drug International Limited (Unit 2)
|
Bangladesh
|
Initial
|
08 May 2024
|
08 May 2029
|
| View |
|
DRP-15130
|
Carboplatin
|
Neoplin-150
|
10 mg/mL (150 mg/ 15 mL)
|
Solution for Injection (I.V)
|
Antineoplastic Agent (Platinum Compound)
|
Drug International Limited (Unit 2)
|
Bangladesh
|
Initial
|
08 May 2024
|
08 May 2029
|
| View |
|
DRP-15135
|
Divalproex sodium (equivalent to Valproic Acid)
|
Divalfred
|
500 mg
|
Extended-Release Tablet
|
Anticonvulsant/Antiepileptic
|
Fredun Pharmaceuticals Limited
|
India
|
Initial
|
08 May 2024
|
08 May 2029
|
| View |
|
DRHR-2354
|
Povidone-Iodine
|
TheraPREP
|
10% w/v (equivalent to 1% w/v Iodine)
|
Solution Pre-Filled In Applicator
|
Antiseptic
|
CareNow Medical Private Limited
|
India
|
Initial
|
07 May 2024
|
07 May 2029
|
| View |
|
DRP-15119
|
Diphenhydramine
|
Hyapin
|
50 mg/mL
|
Solution for Injection (IM/IV)
|
Antihistamine
|
Hebei Tiancheng Pharmaceutical Co., Ltd.
|
China
|
Initial
|
08 May 2024
|
08 May 2029
|
| View |
|
DRP-15114
|
Acetylcysteine
|
Breathac
|
100 mg/mL (300 mg/3 mL)
|
Solution for Inhalation
|
Mucolytic
|
Hebei Tiancheng Pharmaceutical Co., Ltd.
|
China
|
Initial
|
03 May 2024
|
03 May 2029
|
| View |
|
DRP-15117
|
Acetylcysteine
|
Hemucil
|
600 mg
|
Effervescent Tablet
|
Mucolytic
|
Hebei Tiancheng Pharmaceutical Co., Ltd.
|
China
|
Initial
|
08 May 2024
|
08 May 2029
|
| View |
|
DR-XY49074
|
Omidenepag isopropyl
|
Eybelis-S
|
20 mcg/mL (0.002% w/v)
|
Sterile Ophthalmic Solution
|
Anti-glaucoma Preparation
|
Santen Pharmaceutical Co., Ltd. (Noto Plant)
|
Japan
|
Monitored Release
|
10 May 2024
|
10 May 2029
|
| View |
|
DRP-15132
|
Cytarabine
|
CytaGet
|
100 mg/mL (500 mg/5 mL)
|
Solution for Injection
(IV/SC/Intrathecal)
|
Antineoplastic
|
Venus Remedies, Limited
|
India
|
Initial
|
10 May 2024
|
10 May 2029
|
| View |
|
DRP-15131
|
Cytarabine
|
CytaGet
|
100 mg/mL
|
olution for Injection (IV/SC/Intrathecal)
|
Antineoplastic
|
Venus Remedies, Limited.
|
India
|
Initial
|
10 May 2024
|
10 May 2029
|
| View |
|
DR-XY49078
|
Bisoprolol fumarate
|
Bisovell
|
5 mg
|
Film Coated Tablet
|
Beta Blocking Agent
|
PT. Novell Pharmaceutical Laboratories
|
Indonesia
|
Initial
|
13 May 2024
|
13 May 2029
|
| View |
|
DRP-15144
|
Cefotaxime (as sodium) + Sulbactam (as sodium)
|
Sefoxim-SB 1500
|
1.5 g
|
Powder for Injection (IM/IV)
|
Antibacterial (Third-generation Cephalosporin)
|
Sakar Healthcare Limited
|
India
|
Initial
|
13 May 2024
|
13 May 2029
|
| View |
|
DRP-15122
|
Clindamycin (as phosphate) + Adapalene
|
Nioclean-AD
|
10 mg/1 mg per g (1%w/w/0.1% w/w)
|
Topical Gel.
|
Anti-acne Preparation
|
KLM Laboratories Pvt. Ltd.
|
India
|
Initial
|
13 May 2024
|
13 May 2029
|
| View |
|
DRHR-2359
|
Tretinoin
|
None
|
250 mcg/g (0.025% w/w)
|
Topical Cream
|
Anti-acne
|
Altum International Cosmeceutical Manufacturing
Inc.
|
Philippines
|
Initial
|
10 May 2024
|
10 May 2029
|
| View |
|
DRHR-2357
|
Hydroquinone + Tretinoin
|
None
|
20 mg/250 mcg per g (2%/0.025% w/w)
|
Topical Cream
|
Depigmenting Agent/Anti-acne
|
Altum International Cosmeceutical Manufacturing
Inc.
|
Philippines
|
Initial
|
10 May 2024
|
10 May 2029
|