| View |
|
DR-XY49229
|
Flurbiprofen
|
Strepsils MaxPro Direct
|
8.75 mg/0.5 mL
|
Oromucosal Spray (Mint and Cherry Flavor)
|
Throat Preparation (for Sore Throat)
|
Reckitt Benckiser Healthcare (Thailand) Ltd.
|
Thailand
|
Initial (OTC)
|
27 September 2024
|
27 September 2029
|
| View |
|
DRP-3549-08
|
Azithromycin (as dihydrate)
|
None
|
500 mg
|
Film-coated Tablet
|
Antibacterial (Macrolide)
|
Hizon Laboratories, Inc.
|
Philippines
|
CLIDP Conversion
|
09 April 2023
|
16 September 2026
|
| View |
|
DR-XY49342
|
Baclofen
|
Spilogen
|
10mg
|
Tablet
|
Muscle Relaxant (Centrally Acting Agent)
|
Celogen Generics Private Ltd.
|
India
|
Initial [Re-application]
|
25 February 2025
|
25 February 2030
|
| View |
|
DRP-16386
|
Fluorouracil
|
FluoroGet-500
|
50mg/mL (500mg/10mL)
|
Solution for Injection
(IV Infusion)
|
Antineoplastic Agent (Pyrimidine analogue)
|
Beta Drugs Limited
|
India
|
Initial
|
26 February 2025
|
26 February 2030
|
| View |
|
DRP-16387
|
Metoclopramide (as hydrochloride)
|
Liothyl
|
5 mg/mL (10 mg/2 mL)
|
Solution for Injection (I.M./I.V.)
|
Anti-Emetic
|
Y.S.P. Industries (M)
|
Malaysia
|
Initial (Reapplication)
|
26 February 2025
|
26 February 2030
|
| View |
|
DRP-16396
|
Dutasteride + Tamsulosin Hydrochloride
|
Amso-D
|
500 mcg/400 mcg
|
Capsule
|
Alpha-Adrenoceptor Antagonist
|
Zim Laboratories Limited
|
India
|
Initial
|
28 February 2025
|
28 February 2030
|
| View |
|
DRP-16388
|
Iron (as Iron Sucrose)
|
Biferron
|
20 mg/mL (100 mg/5 mL)
|
Solution
|
Antianemic
|
Kwality Pharmaceuticals Ltd.
|
India
|
Initial (Reapplication).
|
26 February 2025
|
26 February 2030
|
| View |
|
DRP-16389
|
Mometasone Furoate
|
Sagamome
|
1 mg/g (0.1 w/w%)
|
Topical Cream
|
Glucocorticoid
|
Yash Medicare Private Limited
|
India
|
Initial (Reapplication)
|
26 February 2025
|
26 February 2030
|
| View |
|
DRP-16390
|
Norepinephrine (as bitartrate)
|
Norfine
|
2 mg/2 mL
|
Solution for Injection (I.V.)
|
Adrenergic and Dopaminergic Agent
|
Kwality Pharmaceuticals Ltd.
|
India
|
Initial (Reapplication)
|
26 February 2025
|
26 February 2030
|
| View |
|
DRP-16403
|
Hydroquinone
|
Dr. Alvin® Bleaching
|
40 mg (4% w/w) per gram
|
Topical Lotion
|
Anti-hyperpigmentation
|
Carmel Laboratories, Inc.
|
Philippines
|
Initial
|
04 March 2025
|
04 March 2030
|
| View |
|
DR-XY49344
|
Milrinone (as lactate)
|
Milicor
|
1 mg/mL (10 mg/10 mL)
|
Solution for I.V. Injection
|
Cardiac Stimulant (Phosphodiesterase Inhibitor)
|
Samarth Life Sciences Pvt. Ltd. (Unit II)
|
India
|
Monitored Release
|
26 February 2025
|
26 February 2030
|
| View |
|
DRP-16405
|
Ivabradine (as hydrochloride)
|
Ivapro 7.5
|
7.5 mg
|
Film-Coated Tablet
|
Anti-Angina
|
Medreich Limited (Unit 3)
|
India
|
Initial
|
04 March 2025
|
04 March 2030
|
| View |
|
DRP-16391
|
Iron Sucrose (as Ferric Hydroxide Sucrose Complex)
|
Surcon
|
20 mg/mL (100 mg/5 mL)
|
Solution for Injection (IV)
|
Anti-anemia
|
Makcur Laboratories Limited
|
India
|
Initial
|
26 February 2025
|
26 February 2030
|
| View |
|
DRP-16380
|
Paracetamol + Phenylephrine HCl + Chlorphenamine
Maleate
|
Fluaid
|
500 mg/10 mg/2 mg
|
Tablet
|
Analgesic Antipyretic/Nasal Decongestant/Antihistamine
|
Diamond Laboratories Inc.
|
Philippines
|
Initial
|
25 February 2025
|
25 February 2030
|
| View |
|
DRP-162392
|
Fulvestrant
|
Femcord
|
250 mg/5 mL
|
Solution For Injection (Im/Iv Prefilled Syringe)
|
Anti-estrogen
|
Intas Pharmaceutical Limited
|
India
|
Initial (Re-application)
|
28 February 2025
|
28 February 2030
|
| View |
|
DRP-16360
|
Multivitamins + Minerals.
|
Efergen
|
Formulation:
Each Effervescent Tablet contains:
Ascorbic Acid (Vit. C)
Calcium (as calcium carbonate and calcium pantothenate)
500 mg 100 mg
Magnesium (as magnesium carbonate heavy and magnesium sulphate)
100 mg
50 mg
Nicotinamide (Vit. B3)
Pantothenic acid (as calcium Pantothenate) (Vit. B5)
23 mg
Thiamine Hydrochloride (Vit. B1)
15 mg
Riboflavin (as riboflavin sodium phosphate) (Vit. B2)
15 mg
10 mg
10 mg
Pyridoxine Hydrochloride (Vit. B6)
Zinc (as zinc citrate dihydrate)
Folic Acid
Biotin (Vit. H)
Cyanocobalamin (Vit. B12)
|
Effervescent Tablet
|
Vitamin & Minerals
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial
|
28 February 2025
|
28 February 2027
|
| View |
|
DRP-16361
|
Multivitamins + Minerals + Lutein + Lycopene
|
Centrogen Advance
|
4000 IU/ 600 mcg/ 500 mcg/ 2.18 mg/ 3.2 mg/ 15 mg/ 10 mg/ 6 mg/ 45 mcg/ 400 mcg/ 22 mcg/ 90 mg/ 600 IU/ 50 IU/ 25 mcg/ 200 mg/ 35 mcg/ 500 mcg/ 150 mcg/ 5 mg/ 50 mg/ 3.5 mg/ 50 mg/ 80 mg/ 55 mcg/ 7.5 mg
|
Film-Coated Tablet
|
Azarias Pharmaceutical Laboratories Inc.
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial
|
28 February 2025
|
28 February 2027
|
| View |
|
DRP-16407
|
Guaifenesin + Phenylpropanolamine HC1 Chlorphenamine Maleate
|
Pluragen
|
100 mg 6.5 mg/2 mg per 45 mL
|
Syrup (Cherry Flavor)
|
Antihistamine/Nasal Decongestant/Expectorant
|
Azarias Pharmaceutical Laboratories
|
Philippines
|
Initial
|
04 March 2025
|
04 March 2030
|
| View |
|
DRP-16236
|
Carmellose Sodium
|
Blysod
|
5 mg/mL (0.5% w/v)
|
Ophthalmic Solution (Eye Drops)
|
Eye Lubricant
|
Makcur Laboratories Limited
|
India
|
Initial
|
27 February 2025
|
27 February 2030
|
| View |
|
DRHR-2410
|
Isopropyl Alcohol
|
Pureshield
|
70 mL per 100 mL (70% v/v Solution)
|
Scented
|
Antiseptic/Disinfectant
|
Medipak Manufacturing Inc.
|
Philippines
|
Initial
|
25 February 2025
|
25 February 2027
|