| View |
|
DRP-11968
|
Losartan potassium
|
None
|
50 mg
|
Film-Coated Tablet
|
Angiotensin II receptor blocker (ARB)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
25 May 2022
|
25 May 2027
|
| View |
|
DRP-11942
|
Pantoprazole (As Sodium)
|
None
|
40mg
|
Delayed-Release Capsule
|
Proton pump inhibitor
|
Zim Laboratories Limited
|
India
|
Initial
|
23 May 2022
|
23 May 2027
|
| View |
|
DRP-11969
|
Losartan potassium + Hydrochlorothiazide
|
None
|
100 mg/25 mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker (ARB)/Diuretic
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
25 May 2022
|
25 May 2027
|
| View |
|
DRP-12006
|
Losartan Potassium
|
None
|
100 mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker (ARB)
|
United International Pharma Co. Ltd.
|
Vietnam
|
Initial
|
27 May 2022
|
27 May 2027
|
| View |
|
DRP-11972
|
Brimonidine (as Tartrate) + Timolol (as Maleate)
|
None
|
2 mg/5 mg per mL
|
Sterile Ophthalmic Solution
(Drops)
|
Antiglaucoma and Miotic (Beta blocking agent)
|
Indoco Remedies Limited
|
India
|
Initial
|
25 May 2022
|
25 May 2025
|
| View |
|
DRP-11502
|
Montelukast (as sodium)
|
Montefend
|
10 mg
|
Film-Coated Tablet
|
Leulotriene receptor antagonist
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
23 May 2022
|
23 May 2027
|
| View |
DR-XY48030_PI_01.pdf
|
DR-XY48030
|
Esflurbiprofen
|
Locoa
|
40 mg
|
Transdermal Patch
|
-
|
Tokuhon Corporation (Miyashiro Factory)
|
Japan
|
Monitored Release
|
20 May 2022
|
20 May 2027
|
| View |
|
DR-XY48053
|
Lenalidomide
|
Lenangio 5
|
5 mg
|
Capsule
|
Immunosuppressant
|
Dr. Reddy's Laboratories Ltd. (Formulation Technical
Operations Unit-VII)
|
India
|
Monitored Release
|
26 May 2022
|
26 May 2025
|
| View |
|
DR-XY48050
|
Lenalidomide
|
Lenangio 25
|
25 mg
|
Capsule
|
-
|
Dr. Reddy's Laboratories Ltd. (Formulation Technical
Operations Unit-VII)
|
India
|
Monitored Release
|
26 May 2022
|
26 May 2025
|
| View |
|
DR-XY48051
|
Lenalidomide
|
Lenangio 15
|
15 mg
|
Capsule
|
-
|
Dr. Reddy's Laboratories Ltd. (Formulation Technical
Operations Unit-VII)
|
India
|
Monitored Release
|
26 May 2022
|
26 May 2025
|
| View |
|
DR-XY48052
|
Lenalidomide
|
Lenangio 10
|
10 mg
|
Capsule
|
Immunosuppressant
|
Dr. Reddy's Laboratories Ltd. (Formulation Technical
Operations Unit-VII)
|
India
|
Monitored Release
|
26 May 2022
|
26 May 2025
|
| View |
|
BR-1401
|
Trastuzumab
|
Kanjinti
|
150 mg
|
Powder For Concentrate For Solution For Infusion (IV)
|
-
|
Amgen Technology (Ireland) Unlimited Company
|
Ireland
|
Initial
|
20 May 2022
|
20 May 2027
|
| View |
|
DR-XY 48040
|
Dexmedetomide (as Hydrochloride)
|
Icunes
|
100 mcg/mL
|
Concentrate for Solution for Intravenous InfusionSolution for Injection
|
Hypnotic/Sedative
|
PT. Novell Pharmaceutical Laboratories
|
Indonesia
|
Initial
|
25 May 2022
|
25 May 2027
|
| View |
|
DRP-11997
|
Hydrocortisone (as sodium succinate)
|
Hydrodex
|
100 mg
|
Powder For Solution For Injection Or Infusion
|
Corticosteroid (Glucocorticoid)
|
Laboratorio Italiano Biochimico Farmaceutico Lisapharma S.p.A.
|
Italy
|
Initial
|
27 May 2022
|
27 May 2027
|
| View |
|
DR-XY48043
|
Esmolol hydrochloride
|
Esmo-IV
|
10 mg/mL
|
Solution for Injection (IV)
|
Beta Adrenoceptor Blocker
|
Myungmoon Pharmaceutical Co., Ltd.
|
Korea
|
Initial
|
26 May 2022
|
26 May 2027
|
| View |
|
DR-XY48055
|
Doxofylline
|
Dilatair
|
200 mg
|
Tablet
|
Bronchodilator
|
Ajanta Pharma Limited
|
India
|
Initial
|
26 May 2022
|
26 May 2027
|
| View |
|
DRP-11920
|
Cefepime (as hydrochloride)
|
Deltacef
|
1g
|
Powder for Injection (IM/IV)
|
Antibacterial (Fourth-generation Cephalosporin)
|
Medochemie (Far East) Ltd., (Aseptic Cephalosporin Facility)
|
Vietnam
|
Initial
|
20 May 2022
|
20 May 2027
|
| View |
|
DR-XY48062
|
Deflazacort
|
Defal
|
6 mg
|
Tablet
|
-
|
Faes Farma, S.A.
|
Spain
|
Monitored Release
|
27 May 2022
|
27 May 2025
|
| View |
|
DRP-11996
|
Fluticasone propionate
|
Dalman
|
50 mcg per actuation (0.05% w/w)
|
Aqueous Suspension.
for Inhalation (Nasal Spray)
|
Corticosteroid
|
Drogsan Ilaclari Sanayi ve Ticaret A.S.
|
Turkey
|
Initial (Reconstruction)
|
31 July 2024
|
01 August 2029
|
| View |
|
DRP-11914
|
Metoprolol Tartrate
|
Betacor
|
100 mg
|
Tablet
|
Beta-blocking Agent
|
Drugmaker's Laboratories, Inc.
|
Philippines
|
Renewal
|
08 March 2024
|
20 May 2029
|