| View |
|
DRP-11783
|
Amlodipine (As Besilate)
|
Avtorex
|
10mg
|
Tablet
|
Calcium Channel Blocker (Dihydropyridine Derivative)
|
Replek Farm Ltd.
|
Macedonia
|
Initial
|
28 April 2022
|
28 April 2027
|
| View |
|
DRP-11784
|
Amlodipine (as besilate)
|
Avtorex
|
5mg
|
Tablet
|
Calcium Channel Blocker (Dihydropyridine
Derivative)
|
Replek Farm Ltd.
|
Macedonia
|
Initial
|
28 April 2022
|
28 April 2027
|
| View |
|
DR-XY47955
|
Cefuroxime (as axetil)
|
None
|
500 mg
|
Film-Coated Tablet
|
Antibacterial (Cephalosporin)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
22 April 2022
|
22 April 2027
|
| View |
|
DR-XY47956
|
Cefuroxime (As Axetil)
|
Rovix
|
500 mg
|
Film-Coated Tablet
|
Antibacterial (Cephalosporin)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
22 April 2022
|
22 April 2027
|
| View |
|
DR-XY47957
|
Cefuroxime (As Axetil)
|
Medzyme
|
500 mg
|
Film-Coated Tablet
|
Antibacterial (Cephalosporin)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
22 April 2022
|
22 April 2027
|
| View |
|
DR-XY47958
|
Cefuroxime (As Axetil)
|
Zefur
|
500 mg
|
Film Coated Tablet
|
Antibacterial (Cephalosporin)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
22 April 2022
|
22 April 2027
|
| View |
|
DRP-11686
|
Cefuroxime
|
None
|
250 mg
|
Film Coated Tablet
|
Second Generation Cephalosporins
|
Sance Laboratories Pvt. Ltd.
|
India
|
Initial
|
13 April 2022
|
13 April 2027
|
| View |
|
DR-XY47964
|
Levodopa + Carbidopa
|
None
|
250 mg / 25 mg
|
Tablet
|
Anti-Parkinson Drug (Dopaminergic Agent)
|
Micro Labs Limited
|
India
|
Initial
|
25 April 2022
|
25 April 2027
|
| View |
|
DR-XY47962
|
Simvastatin
|
Vastilan
|
20 mg
|
Film-Coated Tablet
|
Lipid Modifying Agent (HMG COA Reductase Inhibitor)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
25 April 2022
|
25 April 2027
|
| View |
|
DR-XY47961
|
Simvastatin
|
Vastilan
|
40 mg
|
Film-Coated Tablet
|
Lipid Modifying Agent (HMG COA Reductase Inhibitor)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
25 April 2022
|
25 April 2027
|
| View |
|
DR-XY35736
|
Clarithromycin
|
Klaz
|
250 mg/5 mL
|
Granules For Oral Injection
|
-
|
Amherst Laboratories, Inc.
|
Philippines
|
-
|
27 April 2022
|
27 April 2027
|
| View |
|
DR-XY47979
|
Teneligliptin (as Hemipentahydrobromide hydrate)
Tenglyn
|
Tenglyn
|
20 mg
|
Film Coated Tablet
|
Antidiabetic Agent (Dipeptidyl peptidase 4 (DPP-4) inhibitors)
|
Cadila Healthcare Limited
|
India
|
Monitored Release (MR)
|
28 April 2022
|
28 April 2027
|
| View |
|
DR-XY47963
|
Simvastatin
|
Forcad
|
10 mg
|
Film-Coated Tablet
|
Lipid Modifying Agent (HMG COA Reductase Inhibitor
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
25 April 2022
|
25 April 2027
|
| View |
DR-XY47986_PI_01.pdf
|
DR-XY47986
|
Olmesartan Medoxomil + Amlodipine (as besilate)
|
Alzor CCB
|
40mg/5mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blockers (ARBs) and Calcium Channel Blockers
|
Ajanta Pharma Limited
|
India
|
Initial (from Monitored Release status) [Reconstruction]
|
08 February 2023
|
29 April 2027
|
| View |
DRP-11782_PI_01.pdf
|
DRP-11782
|
Dichlorobenzyl alcohol + Amylmetacresol + Lidocaine
hydrochloride
|
Trosoothe Plus
|
1.2 mg/ 600 mcg/ 10 mg
|
Lozenge (Orange Flavor)
|
Antiseptic/Anesthetic
|
Unique Pharmaceutical Laboratories (A Division of J.B.
Chemicals & Pharmaceuticals Ltd.)
|
India
|
Monitored Release
|
28 April 2022
|
28 April 2027
|
| View |
|
DRP-11742
|
Olopatadine Hydrochloride
|
Dinopat
|
1mg/mL (0.1% w/v)
|
Ophthalmic Solution
|
Decongestant and Antiallergic
|
Axa Parenterals Limited
|
India
|
Initial (Reconstruction)
|
12 August 2024
|
25 April 2027
|
| View |
|
DR-XY47931
|
Ketoconazole + Clobetasol Propionate
|
None
|
10 mg/ 500 mcg per gram
|
Cream
|
Antifungal / Corticosteroid
|
Front Pharmaceutical PLC
|
China
|
Initial
|
12 April 2022
|
12 April 2027
|
| View |
|
DR-XY47934
|
Glutathione
|
Staluta 600
|
600mg
|
Lyophilization Powder For Injection (IM/IV)
|
Antidotes
|
Furen Pharmaceutical Group Co., Ltd.
|
China
|
Initial
|
13 April 2022
|
13 April 2027
|
| View |
|
DRP-11665
|
Esomeprazole (as Sodium)
|
S-QMZ
|
40 mg
|
Lyophilized Powder For Injection (IV)
|
Proton pump inhibitor
|
Pt. Ferron Par Pharmaceuticals
|
Indonesia
|
Initial
|
25 April 2022
|
25 April 2027
|
| View |
|
DRP-11752
|
Drospirenone + Ethinylestradiol
|
Dronis
|
3 mg/20 mcg
|
Film-Coated Tablet
|
Hormonal Contraceptive
|
Sun Pharmaceutical Industries Ltd.
|
India
|
Initial (Reconstruction)
|
31 May 2024
|
26 April 2027
|