| View |
|
DR-XY47565
|
Fluconazole
|
None
|
2 mg/mL (100 mg/50 mL, 200 mg/100 mL, and 400 mg/200 mL)
|
Solution for Intravenous Infusion
|
-
|
B. Braun Medical, SA
|
Spain
|
-
|
29 November 2021
|
29 November 2026
|
| View |
|
DR-XY47566
|
Acetylcysteine
|
None
|
100 mg
|
Granules For Oral Suspension
|
-
|
Northfield Laboratories, Inc.
|
Philippines
|
-
|
29 November 2021
|
29 November 2026
|
| View |
|
DR-XY47567
|
Oral Rehydration Salts
|
None
|
Formulation Each tablet contains: Dextrose Anhydrous Sodium Chloride Sodium Bicarbonate Potassium Chloride
2g 350mg 250mg 150mg
|
Tablet
|
Electrolyte with Carbohydrates
|
United International Pharma Co. Ltd.
|
Vietnam
|
Initial
|
26 November 2021
|
26 November 2026
|
| View |
|
DR-XY47568
|
Ticagrelor
|
None
|
60 mg
|
Film-Coated Tablet
|
Antithrombotic Agent (Platelet Aggregation Inhibitor)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Monitored Release
|
29 November 2021
|
29 November 2024
|
| View |
|
DR-XY47569
|
Sitagliptin (as phosphate monohydrate) + Metformin
hydrochloride
|
None
|
50 mg/500 mg
|
Film-Coated Tablet
|
Combination of Oral Blood Glucose Lowering Drugs
|
Lloyd Laboratories, Inc.
|
Philippines
|
-
|
29 November 2021
|
29 November 2026
|
| View |
|
DR-XY47570
|
Cefuroxime (as Sodium)
|
Texim
|
750 mg
|
Powder for Injection (I.M./I.V.)
|
-
|
Theon Pharmaceuticals Limited
|
India
|
-
|
29 November 2021
|
29 November 2026
|
| View |
|
DR-XY47571
|
Trimetazidine hydrochloride
|
Terazidine
|
35mg
|
Modified Release Tablet
|
-
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial (Correction)
|
20 May 2022
|
29 November 2026
|
| View |
|
DR-XY47572
|
Rosuvastatin (as Calcium)
|
Crestodix-20
|
20mg
|
Film Coated Tablet
|
Lipid Modifying Agent (HMG COA Reductase Inhibitor)
|
Zim Laboratories Limited
|
India
|
Initial
|
29 November 2021
|
29 November 2026
|
| View |
|
DR-XY47573
|
Rosuvastatin (as Calcium)
|
Crestodix-10
|
10mg
|
Film Coated Tablet
|
-
|
Zim Laboratories Limited
|
India
|
-
|
29 November 2021
|
29 November 2026
|
| View |
DR-XY47574_PI_01.pdf
|
DR-XY47574
|
Cilnidipine
|
Cildine
|
10mg
|
Film-Coated Tablet
|
-
|
Ajanta Pharma Limited
|
india
|
-
|
01 December 2021
|
01 December 2026
|
| View |
DR-XY47575_PI_01.pdf
|
DR-XY47575
|
Cilnidipine
|
Cildine
|
20mg
|
Film-Coated Tablet
|
Calcium Channel Blocker (Dihydropyridine Derivative)
|
Ajanta Pharma Limited
|
India
|
Monitored Release
|
01 December 2021
|
01 December 2026
|
| View |
|
DR-XY47576
|
Multivitamins
|
Nerv-E
|
Formulation: Each film-coated tablet contains: Thiamine mononitrate (Vitamin B1)-300mg Pyridoxine Hydrochloride (Vitamin B6)-100mg Cyanocobalamin (Vitamin B12)-1 mg di-Alpha Tocopheryl acetate (Vitamin E)-100IU
|
Film-Coated Tablet
|
Vitamins
|
J.M. Tolmann Laboratories, Inc.
|
Philippines
|
-
|
01 December 2021
|
01 December 2026
|
| View |
|
DR-XY47578
|
Perampanel
|
Fycompa
|
500 mcg/ mL
|
Oral Suspension
|
-
|
Delpharm Huningue SAS
|
France
|
-
|
02 December 2021
|
02 December 2026
|
| View |
|
DR-XY47579
|
Desflurane
|
Desflo
|
100% w/w Liquid for Inhalation
|
Liquid for Inhalation
|
General Anesthetic (Halogenated Hydrocarbon)
|
Shanghai Henrui Pharmaceutical Co., Ltd.
|
China
|
Monitored Release
|
03 December 2021
|
03 December 2024
|
| View |
|
DR-XY47580
|
Propofol
|
Folanes
|
10 mg/mL (1% w/v)
|
Emulsion for Injection
(I.V./Infusion)
|
General Anesthetic (Short-acting Anesthetic)
|
Dongkook Pharmaceutical Co., Ltd.
|
Korea
|
Initial (Re-Issuance)
|
02 August 2022
|
03 December 2026
|
| View |
|
DR-XY47581
|
Efavirenz
|
Efavir
|
600 mg
|
Film Coated Tablet
|
Antiviral (Non-Nucleoside Reverse Transcriptase
Inhibitor)
|
Cipla Limited - Goa (Unit IV)
|
India
|
Initial
|
07 December 2021
|
07 December 2024
|
| View |
|
DR-XY47582
|
Dolutegravir (as sodium)
|
Santigrase
|
50 mg
|
Film Coated Tablet
|
-
|
Cipla Limited - Indore SEZ (Unit IV)
|
India
|
-
|
07 December 2021
|
07 December 2024
|
| View |
|
DR-XY47583
|
Lamivudine + Zidovudine + Nevirapine
|
Duovir-N
|
150 mg/300 mg/200 mg
|
Film Coated Tablet
|
-
|
Cipla Limited - Goa (Unit VII)
|
India
|
-
|
07 December 2021
|
07 December 2024
|
| View |
|
DR-XY47584
|
Efavirenz + Emtricitabine + Tenofovir disoproxil
fumarate
|
Viraday
|
600 mg/200 mg/300 mg
|
Film Coated Tablet
|
Antiviral Combination
|
Cipla Limited - Goa (Unit VII)
|
India
|
Monitored Release
|
07 December 2021
|
07 December 2024
|
| View |
|
DR-XY47585
|
Efavirenz + Emtricitabine + Tenofovir disoproxil
fumarate
|
Trioday
|
600 mg/300 mg/300 mg
|
Film Coated Tablet
|
-
|
Cipla Limited - Goa (Unit VII)
|
India
|
-
|
07 December 2021
|
07 December 2024
|