| View |
DR-XY44998_PI_01.pdf
|
DR-XY44998
|
Dabrafenib (As Mesilate)
|
Tafinlar
|
75 mg
|
Capsule
|
-
|
Glaxo Operations UK Limited Trading as Glaxo
Wellcome Operations
|
United Kingdom
|
Initial (from Monitored release)
|
02 December 2022
|
02 February 2026
|
| View |
DR-XY44999_PI_01.pdf
|
DR-XY44999
|
Dabrafenib (As Mesilate)
|
Tafinlar
|
50 mg
|
Capsule
|
-
|
Glaxo Operations UK Limited Trading as Glaxo Wellcome Operations
|
United Kingdom
|
Initial (from Monitored release)
|
02 December 2022
|
02 February 2026
|
| View |
|
DR-XY45003
|
Omeprazole
|
Miracid
|
20mg
|
Delayed-Release Capsule
|
-
|
Berlin Pharmaceutical Industry Co., Ltd.
|
Thailand
|
-
|
12 April 2021
|
22 January 2026
|
| View |
|
DR-XY45005
|
Phosphatidyl Choline + Multivitamins
|
Hepamed
|
Formulation Each Soft Gel Capsule contains: Phosphatidyl Choline-300 mg Thiamine Mononitrate (Vitamin B1)-6 mg Riboflavin (Vitamin B2)-6 mg Pyridoxine (Vitamin B6)-6 mg Nicotinamide (Vitamin B3)-30 mg Cyanocobalamin (Vitamin B12)-60 mcg dl-alpha-Tocopherol Acetate (Vitamin E)- 6 mg (equivalent to 6 IU)
|
Soft Gel Capsule
|
-
|
Northfield Laboratories, Inc.
|
Philippines
|
-
|
02 March 2021
|
02 February 2026
|
| View |
|
DR-XY45006
|
Phosphatidyl Choline + Vitamin B-Complex + Vitamin E
|
Essenphos
|
300mg/6mg/6mg/6mg/30mg/6mcg/6mg
|
Softgel Capsule
|
-
|
Northfield Laboratories, Inc.
|
Philippines
|
-
|
17 February 2021
|
22 January 2026
|
| View |
|
DR-XY45007
|
Phosphatidyl Choline + Multivitamins
|
Essenvit Forte
|
Formulation: Each Softgel capsule contains: Phosphatidyl Choline-300 mg Thiamine Mononitrate (Vitamin B1) -6 mg Riboflavin (Vitamin B2)-6 mg Nicotinamide (Vitamin B3)- 30 mg Pyridoxine Hydrochloride (Vitamin B6)-6 mg Cyanocobalamin (Vitamin B12)-6 mcg dl-alpha Tocopheryl Acetate (Vitamin E)
-6 mg (equivalent to 6 IU)
|
Softgel Capsule
|
-
|
Northfield Laboratories Inc.
|
Philippines
|
-
|
04 March 2021
|
22 January 2026
|
| View |
|
DR-XY45019
|
Desonide
|
Dosetil
|
0.5 mg/g (0.05 % w/w)
|
Cream
|
Topical Corticosteroid
|
Glenmark Pharmaceuticals Ltd. (Unit II)
|
India
|
Automatic Renewal
|
02 December 2020
|
29 January 2026
|
| View |
|
DR-XY45021
|
Febuxostat
|
Urica
|
80mg
|
Film-Coated Tablet
|
-
|
Advanced Chemical Industries (ACI) Ltd.
|
Bangladesh
|
Initial [from Monitored Release]
|
30 May 2022
|
29 January 2026
|
| View |
|
DR-XY45024
|
Minoxidil
|
Regain
|
50mg/mL (5% w/v)
|
Topical Solution
|
-
|
Jewim Pharmaceutical (Shandong) Co., Ltd.
|
China
|
-
|
08 February 2021
|
01 February 2026
|
| View |
|
DR-XY45028
|
Co-Amoxiclav
|
Hypermox
|
625mg
|
Film-Coated Tablet
|
-
|
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
|
China
|
-
|
10 February 2021
|
02 February 2026
|
| View |
|
DR-XY45032
|
Pregabalin
|
Ligaba
|
75 mg
|
Capsule
|
-
|
MSN Laboratories Ltd. (Formulations Division)
|
India
|
-
|
04 February 2021
|
03 February 2026
|
| View |
|
DR-XY45033
|
Pregabalin
|
Ligaba
|
150 mg
|
Capsule
|
-
|
MSN Laboratories Ltd. (Formulations Division)
|
India
|
-
|
04 February 2021
|
03 February 2026
|
| View |
|
DR-XY45052
|
Metformin Hydrochloride
|
Hovideuform Xr
|
500mg
|
Extended Release Tablet
|
-
|
Hovid Berhad
|
Malaysia
|
-
|
29 October 2020
|
10 February 2026
|
| View |
DR-XY45059_PI_01.pdf
|
DR-XY45059
|
Ceritinib
|
Zykadia
|
150 mg
|
Capsule
|
Anaplastic Lymphoma Kinase (ALK) inhibitor
|
Novartis Pharma Stein
|
Switzerland
|
Initial (from Monitored Release)
|
20 May 2022
|
11 February 2026
|
| View |
|
DR-XY45067
|
Paracetamol + Phenylephrine Hydrochloride +
Chlorphenamine Maleate
|
None
|
125 mg/6.25 mg/500 mcg per 5 mL
|
Syrup
|
Analgesic/Antipyretic/Antihistamine
|
Lloyd Laboratories, Inc.
|
Philippines
|
-
|
29 December 2020
|
16 February 2026
|
| View |
|
DR-XY45068
|
Paracetamol + Phenylephrine Hydrochloride +
Chlorphenamine Maleate
|
None
|
500 mg/25 mg/2 mg
|
Tablet
|
Analgesic-Antipyretic/Nasal Decongestant/Antihistamine
|
Lloyd Laboratories, Inc.
|
Philippines
|
-
|
29 December 2020
|
16 February 2026
|
| View |
|
DR-XY45070
|
Calcium + Cholecalciferol (Vitamin D3) + Minerals
|
Caltrate Advance
|
Formulation: Each Film-coated Tablet contains: Cholecalciferol (Vitamin D3)-500IU Calcium (as Calcium Carbonate 1.5 g)-600mg Magnesium (as Magnesium Oxide 82.9 mg)-50mg Zinc (as Zinc Oxide 9.34 mg)-7.5mg Manganese (as Manganese Sulfate Monohydrate 5.39 mg)-1.75mg Copper (as Copper Sulfate Anhydrous 1.26 mg)-500mcg
|
Film-Coated Tablet
|
-
|
Wyeth Pharmaceutical Co. Ltd.
|
China
|
Automatic Renewal
|
19 April 2021
|
17 February 2026
|
| View |
|
DR-XY45079
|
Spironolactone
|
Spitone-25
|
25mg
|
Tablet
|
-
|
West-Coast Pharmaceutical Works Ltd.
|
Philippines
|
-
|
09 October 2020
|
16 February 2026
|
| View |
|
DR-XY45095
|
Meropenem (As Trihydrate)
|
Meroqure-5
|
500 mg
|
Powder For Injection (I.V.)
|
-
|
Ameda Pharma Pvt. Ltd.
|
India
|
-
|
08 April 2021
|
19 February 2026
|
| View |
|
DR-XY45098
|
Irbesartan
|
Irbez 150
|
150 mg
|
Tablet
|
-
|
Unison Laboratories Co., Ltd.
|
Thailand
|
-
|
31 March 2021
|
19 February 2026
|