| View |
|
DR-XY 47706
|
Rosuvastatin (as zinc) + Ezetimibe
|
Rozuor
|
20mg/10mg
|
Capsule
|
-
|
EGIS Pharmaceuticals PLC
|
Hungary
|
-
|
04 February 2022
|
04 February 2027
|
| View |
|
DR-XY 47745
|
Abemaciclib
|
Yulareb
|
200 mg
|
Film-Coated Tablet
|
Antineoplastic Agent [Protein kinase Inhibitor
(Cyclin-Dependent Kinase (CDK) Inhibitor)]
|
Lilly del Caribe, Inc.
|
United States of America
|
Monitored Release
|
22 February 2022
|
22 February 2027
|
| View |
|
DR-XY 47798
|
Cefotaxime (As Sodium)
|
Anzoxim
|
1 g
|
Powder For Injection (I.M./I.V.)
|
Antibacterial
|
Injectcare Parenterals Pvt. Ltd.
|
India
|
Initial
|
10 March 2022
|
10 March 2027
|
| View |
|
DR-XY 47806
|
Nepafenac
|
Ilevro
|
3 mg/mL (0.3 % w/v)
|
Sterile Ophthalmic Suspension
|
-
|
Alcon-Couvreur NV
|
Belgium
|
Monitored Release
|
16 May 2022
|
10 March 2027
|
| View |
|
DR-XY 47860
|
Calcium Folinate
|
Folivell
|
10mg/mL (50mg/5mL)
|
Solution For Injection (IM/IV)
|
Detoxifying Agents for Antineoplastic Treatment
|
PT. Novell Pharmaceutical Laboratories
|
Indonesia
|
Initial (Correction)
|
18 May 2022
|
30 March 2027
|
| View |
|
DR-XY 47865
|
Fulvestrant
|
Luvestra
|
250 mg per 5 mL
|
Solution for Injection (IM)
|
Anti-Estrogen
|
Ebewe Pharma Ges.mb.H Nfg. Kg
|
Austria
|
Monitored Release
|
30 March 2022
|
30 March 2027
|
| View |
|
DR-XY 47867
|
Rivaroxaban
|
Romriva
|
20 mg
|
Film-Coated Tablet
|
Antithrombotic agents (direct factor Xa inhibitor)
|
Lupin Limited (Unit II)
|
India
|
Monitored Release
|
30 March 2022
|
30 March 2027
|
| View |
|
DR-XY 47869
|
Rivaroxaban
|
Romriva
|
10 mg
|
Film-Coated Tablet
|
Antithrombotic agents (direct factor Xa inhibitor)
|
Lupin Limited (Unit II)
|
India
|
Monitored Release
|
30 March 2022
|
30 March 2027
|
| View |
|
DR-XY 47870
|
Acalabrutinib
|
Calquence
|
100 mg
|
Capsule
|
Antineoplastic agent (Protein Kinase Inhibitor)
|
AstraZeneca AB
|
Sweden
|
Monitored Release
|
30 March 2022
|
30 March 2027
|
| View |
|
DR-XY 47871
|
Candesartan Cilexetil
|
Alvopress
|
32 mg
|
Tablet
|
Angiotensin II-receptor Blocker (ARB)
|
Laboratorios Liconsa, S.A.
|
Spain
|
Monitored Release
|
30 March 2022
|
30 March 2027
|
| View |
|
DR-XY 47897
|
Alendronic acid (as Alendronate sodium) +
Cholecalciferol (Vitamin D3)
|
Maxlen-Plus 5600
|
70 mg/5,600 IU
|
Tablet
|
Biphosphonate-Vitamin D Combination
|
Apotex Inc.
|
Canada
|
Initial
|
04 April 2022
|
04 April 2027
|
| View |
|
DR-XY 47911
|
Calcipotriol
|
None
|
50 mcg/g (0.005% w/w)
|
Topical Gel
|
Antipsoriatic
|
Amherst Laboratories, Inc.
|
Philippines
|
Initial
|
06 April 2022
|
06 April 2027
|
| View |
|
DR-XY 47929
|
Linagliptin + Metformin Hyydrochloride
|
Trajenta Duo
|
2.5mg/1g
|
Film-Coated Tablet
|
Oral Blood Glucose Lowering Drug Combination
|
Boehringer Ingelheim Promeco, S.A. de C.V.
|
Mexico
|
Initial
|
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
|
Drug for Functional Gastrointestinal El Disorders (Propulsive)
|
Korea United Pharm. Inc.
|
Korea
|
Monitored Release
|
25 May 2022
|
25 May 2027
|
| View |
|
DR-XY 48037
|
Ambroxol Hydrochloride
|
None
|
30 mg
|
Tablet
|
Expectorant (Mucolytic)
|
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
|
Oral Blood Glucose Lowering Drug Combination
|
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
|
Hypnotic/Sedative
|
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)
|
Antiglaucoma (Sympathomimetic)
|
Allergan Sales LLC
|
United States of America
|
Monitored Release
|
31 May 2022
|
31 May 2027
|