| View |
|
DR-XY 47897
|
Alendronic acid (as Alendronate sodium) +
Cholecalciferol (Vitamin D3)
|
Maxlen-Plus 5600
|
70 mg/5,600 IU
|
Tablet
|
-
|
Apotex Inc.
|
Canada
|
-
|
04 April 2022
|
04 April 2027
|
| View |
|
DR-XY 47911
|
Calcipotriol
|
None
|
50 mcg/g (0.005% w/w)
|
Topical Gel
|
-
|
Amherst Laboratories, Inc.
|
Philippines
|
-
|
06 April 2022
|
06 April 2027
|
| View |
|
DR-XY 47929
|
Linagliptin + Metformin Hyydrochloride
|
Trajenta Duo
|
2.5mg/1g
|
Film-Coated Tablet
|
-
|
Boehringer Ingelheim Promeco, S.A. de C.V.
|
Mexico
|
-
|
12 April 2022
|
12 April 2027
|
| View |
|
DR-XY 47942
|
Daclatasvir (as dihydrochloride)
|
Virdac 30
|
30 mg
|
Film-Coated Tablet
|
-
|
Hetero Labs Limited (Unit V)
|
India
|
-
|
18 April 2022
|
18 April 2027
|
| View |
|
DR-XY 47943
|
Daclatasvir (as dihydrochloride)
|
Virdac 60
|
60 mg
|
Film-Coated Tablet
|
-
|
Hetero Labs Limited (Unit V)
|
India
|
-
|
18 April 2022
|
18 April 2027
|
| View |
|
DR-XY 48036
|
Mosapride citrate (as dihydrate)
|
Gastiin CR
|
15 mg
|
Controlled-Release Tablet
|
-
|
Korea United Pharm. Inc.
|
Korea
|
Monitored Release
|
25 May 2022
|
25 May 2027
|
| View |
|
DR-XY 48037
|
Ambroxol Hydrochloride
|
None
|
30 mg
|
Tablet
|
-
|
Shandong Yuxin Pharmaceutical Co., Ltd.
|
China
|
Initial
|
25 May 2022
|
25 May 2027
|
| View |
|
DR-XY 48038
|
Linagliptin + Metformin Hyydrochloride
|
Trajenta Duo
|
2.5mg/500mg
|
Film-Coated Tablet
|
-
|
Boehringer Ingelheim Promeco, S.A. de C.V.
|
Mexico
|
Initial
|
25 May 2022
|
25 May 2027
|
| View |
|
DR-XY 48040
|
Dexmedetomide (as Hydrochloride)
|
Icunes
|
100 mcg/mL
|
Concentrate for Solution for Intravenous InfusionSolution for Injection
|
-
|
PT. Novell Pharmaceutical Laboratories
|
Indonesia
|
Initial
|
25 May 2022
|
25 May 2027
|
| View |
|
DR-XY 48074
|
Brimonidine Tartrate
|
Alphagan P
|
1 mg/mL (0.1% w/v)
|
Sterile Ophthalmic Solution (Eye Drops)
|
-
|
Allergan Sales LLC
|
United States of America
|
Monitored Release
|
31 May 2022
|
31 May 2027
|
| View |
|
DR-XY 48101
|
Vancomycin Hydrochloride
|
Vancover
|
125 mg
|
Capsule
|
-
|
Orient Pharma Co., Ltd.
|
Taiwan
|
Monitored Release
|
09 June 2022
|
09 June 2025
|
| View |
|
DR-XY 48110
|
Cyproterone Acetate + Ethinylestradiol
|
Cypress
|
2 mg/35 mcg
|
Tablet
|
-
|
Mylan Laboratories Ltd.
|
India
|
Initial
|
16 June 2022
|
16 June 2027
|
| View |
|
DR-XY 48176
|
Lenalidomide
|
Linadex 25
|
25 mg
|
Capsule
|
-
|
Hetero Labs Limited (Unit-V, Block-VB)
|
India
|
Monitored Release
|
11 July 2022
|
11 July 2025
|
| View |
|
DR-XY 48288
|
Fenofibric Acid
|
None
|
105 mg
|
Softgel Capsule
|
-
|
Amherst Laboratories, Inc.
|
Philippines
|
Monitored Release (Re-application)
|
15 August 2022
|
15 August 2027
|
| View |
|
DR-XY 48289
|
Aciclovir + Hydrocortisone
|
None
|
50 mg/10 mg per gram (5%/1% w/w)
|
Topical Cream
|
-
|
Asian Antibiotics, Inc.
|
Philippines
|
Monitored Release (Re-application)
|
15 August 2022
|
15 August 2027
|
| View |
|
DR-XY 48652
|
Candesartan cilexetil
|
Hyperest
|
8 mg
|
Tablet
|
-
|
Laboratorios Liconsa, S.A.
|
|
Initial
|
24 March 2023
|
24 March 2028
|
| View |
|
DR-XY 48778
|
Omeprazole (as sodium monohydrate).
|
Fluxzol
|
40 mg
|
Lyophilized Powder for Intravenous Injection
|
-
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
22 June 2023
|
22 June 2028
|
| View |
|
DR-XY 48782
|
Propofol
|
Parafol
|
10 mg/mL (1% w/v)
|
Emulsion for Intravenous Injection
|
-
|
Dongkook Pharmaceutical Co., Ltd.
|
Korea
|
Initial
|
23 June 2023
|
23 June 2028
|
| View |
|
DR-XY 48965
|
Carboplatin
|
Platixon
|
450 mg/45 mL (10 mg/mL)
|
Solution for Intravenous
Infusion
|
-
|
Venus Remedies Limited
|
India
|
Initial
|
28 December 2023
|
28 December 2028
|
| View |
|
DR-XY 48966
|
Carboplatin
|
Platixon
|
150 mg/15 mL (10 mg/mL)
|
Solution for Intravenous
Infusion
|
-
|
Venus Remedies Limited
|
India
|
Initial
|
28 December 2023
|
28 December 2028
|