| View |
|
DR-XY47991
|
Dolutegravir (as sodium)
|
Doluvir
|
50 mg
|
Film Coated Tablet
|
Antiviral (Integrase Inhibitor)
|
Micro Labs Limited
|
India
|
Initial
|
29 April 2022
|
29 April 2027
|
| View |
|
DR-XY47992
|
Zinc
|
I-Zn
|
20 mg (equivalent to 55 mg Zinc Sulfate
Monohydrate) / 5mL
|
Syrup (Tutti-Frutti Flavor)
|
Mineral
|
Izmed Laboratories, Corp.
|
Philippines
|
Initial (OTC)
|
02 May 2022
|
02 May 2027
|
| View |
|
DR-XY47993
|
Ascorbic Acid + Zinc + Cholecalciferol (Vitamin D3)
|
Opti-CDZ
|
500 mg (equivalent to 568.18 mg Sodium Ascorbate)/
10 mg (equivalent to 27.5 mg Zinc Sulfate)/1000 IU
|
Capsule
|
Vitamin/Mineral
|
Northfield Laboratories Inc.
|
Philippines
|
Initial
|
06 May 2022
|
06 May 2027
|
| View |
|
DR-XY47994
|
Teneligliptin (as hydrobromide hydrate)
|
Tenemax
|
20 mg
|
Film-Coated Tablet
|
Antidiabetic Agent (Dipeptidyl peptidase 4 (DPP-4) inhibitors)
|
Ajanta Pharma Limited
|
India
|
Monitored Release (MR) (Correction)
|
21 May 2024
|
02 May 2027
|
| View |
|
DR-XY47995
|
Drospirenone + Ethinylestradiol
|
Yanci 20
|
3mg/20mcg
|
Tablet
|
-
|
Mylan Laboratories Ltd.
|
India
|
-
|
04 May 2022
|
04 May 2027
|
| View |
|
DR-XY47996
|
Paracetamol + Thiamine Mononitrate (Vitamin B1) +
Pyridoxine Hydrochloride (Vitamin B6) + Cyanocobalamin (Vitamin B12)
|
Dolo-Neurobion3B®
|
500mg/ 50mg / 100mg / 100mcg
|
Film-Coated Tablet
|
Analgesic/Antipyretic/Vitamins
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial (OTC) correction
|
02 August 2022
|
05 May 2027
|
| View |
|
DR-XY47997
|
Lamivudine + Zidovudine
|
Lavuzid
|
150mg/300mg
|
Film Coated Tablet
|
Antiviral Combination
|
Hetero Labs Limited (Unit III)
|
India
|
Initial
|
05 May 2022
|
05 May 2027
|
| View |
DR-XY47998_PI_01.pdf
|
DR-XY47998
|
Lamivudine + Tenofovir disoproxil fumarate
|
Tenolam
|
300 mg / 300 mg
|
Film-Coated Tablet
|
Antiviral Combination
|
Hetero Labs Limited (Unit III)
|
India
|
Monitored Release
|
05 May 2022
|
05 May 2025
|
| View |
DR-XY47999_PI_01.pdf
|
DR-XY47999
|
Efavirenz + Lamivudine + Tenofovir disoproxil
fumarate
|
Tenolam - E
|
600 mg/300 mg/300 mg
|
Film Coated Tablet
|
Antiviral Combination
|
Hetero Labs Limited (Unit III)
|
India
|
Monitored Release
|
05 May 2022
|
05 May 2025
|
| View |
|
DR-XY48000
|
Fenofibrate
|
None
|
200 mg
|
Capsule
|
Lipid Modifying Agent (Fibrates)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
05 May 2022
|
05 May 2027
|
| View |
|
DR-XY48001
|
Solifenacin succinate
|
Solitor 5
|
5 mg
|
Film-Coated Tablet
|
Urological
|
Torrent Pharmaceuticals Ltd.
|
India
|
Initial (Correction)
|
19 January 2023
|
05 May 2027
|
| View |
DR-XY48002_PI_01.pdf
|
DR-XY48002
|
Dolutegravir (as sodium) + Lamivudine + Tenofovir
disoproxil fumarate
|
None
|
50 mg/ 300 mg/ 300 mg
|
Film-Coated Tablet
|
Antiviral Combination
|
Hetero Labs Limited
|
India
|
Monitored Release
|
05 May 2022
|
05 May 2025
|
| View |
|
DR-XY48003
|
5% Dextrose In Lactated Ringer'S Solution
|
SITI-D5LR
|
Formulation: Each 100 mL contains: Sodium lactate........3.10 mg Potassium chloride.........30 mg Calcium chloride (dihydrate)...........20 mg Sodium chloride...........600 mg Anhydrous Dextrose........5 g
|
Solution For Intravenous Infusion
|
Electrolyte Replenisher
|
Shijiazhuang No.4 Pharmaceutical Co., Ltd.
|
China
|
Initial
|
05 May 2022
|
05 May 2027
|
| View |
|
DR-XY48004
|
Milrinone
|
Myomil
|
1mg/mL
|
Concentrate Solution for Infusion (IV)
|
-
|
Claris Injectables Limited
|
India
|
Monitored Release
|
06 May 2022
|
06 May 2027
|
| View |
|
DR-XY48005
|
Teneligliptin (as hydrobromide hydrate)
|
Tenepride-20
|
20 mg
|
Film Coated tablet
|
Antidiabetic Agent (Dipeptidyl peptidase 4 (DPP-4) inhibitors)
|
Micro Labs Limited
|
India
|
Monitored Release (MR)
|
06 May 2022
|
06 May 2027
|
| View |
|
DR-XY48006
|
Fentanyl (as Citrate)
|
Sublimaze
|
50 mcg/mL
|
Solution for Injection (I.V.)
|
Opioid Analgesic
|
DEMO S.A Pharmaceutical Industry
|
Greece
|
Initial (Correction
|
17 November 2023
|
10 May 2027
|
| View |
|
DR-XY48007
|
Sevelamer Hydrochloride
|
Dephos
|
400 mg
|
Film Coated Tablet
|
Phosphate Binder
|
Aupa Biopharm Co., Ltd.
|
Taiwan
|
Monitored Release
|
18 May 2022
|
18 May 2027
|
| View |
|
DR-XY48008
|
Donepezil Hydrochloride
|
Alzime
|
10 mg
|
Film-Coated Tablet
|
Anticholinesterase
|
Berlin Pharmaceutical Industry Co. Ltd.
|
Thailand
|
Initial
|
10 May 2022
|
10 May 2027
|
| View |
DR-XY48011_PI_01.pdf
|
DR-XY48011
|
Imiquimod
|
Aldara
|
50mg/g (5% w/w)
|
Topical cream
|
Antiviral
|
Ensign Laboratories Pty. Ltd.
|
Australia
|
Initial
|
11 May 2022
|
28 April 2027
|
| View |
|
DR-XY48012
|
Fexofenadine Hydrochloride
|
Zimafen
|
120 mg
|
Film-Coated Tablet
|
-
|
Zim Laboratories Limited
|
India
|
Initial
|
12 May 2022
|
12 May 2027
|