| View |
|
DR-XY48379
|
Ioversol
|
Optiray 320
|
678 mg/mL
|
Solution For Intravascular Injection
|
Radiopaque Contrast Medium
|
Liebel-Flarsheim Company LLC
|
United States of America
|
Initial
|
30 September 2022
|
30 September 2027
|
| View |
|
DR-XY48377
|
Ioversol
|
Optiray 350
|
741 mg/mL
|
Solution For Intravascular Injection
|
Radiopaque Contrast Medium
|
Liebel-Flarsheim Company LLC
|
United States of America
|
Initial
|
30 September 2022
|
30 September 2027
|
| View |
|
DR-XY48378
|
Ioversol
|
Optiray 300
|
636 mg/mL
|
Solution for Intravascular injection
|
Radiopaque Contrast Medium
|
Liebel-Flarsheim Company LLC
|
United States of America
|
Initial [Rx] (Correction)
|
04 October 2023
|
03 October 2027
|
| View |
|
DR-XY48355
|
Nicardipine Hydrochloride
|
Tensilo
|
1 mg/mL
|
Solution For Injection (I.V.)
|
Calcium Channel Blocker
|
PT. Pratapa Nirmala
|
Indonesia
|
Initial
|
29 September 2022
|
29 September 2027
|
| View |
|
DR-XY48384
|
Aluminum Hydroxide + Magnesium Hydroxide
|
Maalox
|
225mg/ 200mg per 5mL
|
Suspension
|
Antacid
|
Sanofi S.p.A.
|
Italy
|
Initial (OTC)
|
30 September 2022
|
30 September 2027
|
| View |
|
DR-XY27488
|
Simvastatin
|
None
|
10 mg
|
Film-Coated Tablet
|
-
|
Amherst Laboratories, Inc.
|
Philippines
|
Automatic Renewal
|
30 September 2022
|
22 October 2027
|
| View |
|
DR-XY48383
|
Sitagliptin (As Phosphate)
|
Glyxera
|
50 mg
|
Film-Coated Tablet
|
Dipeptidyl Peptidase-4 (DDP 4) Inhibitor
|
Beximco Pharmaceuticals Ltd.
|
Bangladesh
|
Initial
|
30 September 2022
|
30 September 2027
|
| View |
|
DRP-12748
|
Gefitinib
|
J-Tinib
|
250 mg
|
Film-Coated Tablet
|
Antineoplastic agent
|
Sinphar Pharmaceutical Co., Ltd. (Taiwan)
|
Taiwan
|
Initial
|
30 September 2022
|
30 September 2027
|
| View |
|
DR-XY48363
|
Iron (as Ferric Hydroxide Sucrose Complex)
|
Eoferon
|
20 mg/mL (100 mg/5 mL)
|
Solution for Injection (IV)
|
-
|
Zee Laboratories Limited
|
India
|
Initial
|
05 October 2022
|
05 October 2027
|
| View |
|
DRP-12735
|
Telmisartan+ Amlodipine (as Besilate)
|
Amlotel
|
80mg/10mg
|
Tablet
|
Angiotensin II Receptor Blocker / Calcium Channel Blocker
|
Evertogen Life Sciences Limited
|
India
|
Initial
|
30 September 2022
|
30 September 2027
|
| View |
|
DRP-12736
|
Telmisartan+ Amlodipine (as Besilate)
|
Amlotel
|
40mg/10mg
|
Tablet
|
Angiotensin II Receptor Blocker / Calcium Channel Blocker
|
Evertogen Life Sciences Limited
|
India
|
Initial
|
30 September 2022
|
30 September 2027
|
| View |
|
DRP-12737
|
Telmisartan+ Amlodipine (as Besilate)
|
Amlotel
|
80mg/5mg
|
Tablet
|
Angiotensin II Receptor Blocker / Calcium Channel Blocker
|
Evertogen Life Sciences Limited
|
India
|
Initial
|
30 September 2022
|
30 September 2027
|
| View |
|
DRP-12738
|
Telmisartan+ Amlodipine (as Besilate)
|
Amlotel
|
40mg/5mg
|
Tablet
|
Calcium Channel Blocker
|
Evertogen Life Sciences Limited
|
India
|
Initial
|
30 September 2022
|
30 September 2027
|
| View |
|
DR-XY48391
|
Amlodipine (as besilate)
|
Eodine 10
|
10 mg
|
Tablet
|
-
|
Ciron Drugs & Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
05 October 2022
|
05 October 2027
|
| View |
|
DR-XY48392
|
Amlodipine (as besilate)
|
Eodine 5
|
5 mg
|
Tablet
|
-
|
Ciron Drugs & Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
05 October 2022
|
05 October 2027
|
| View |
DR-XY48400_PI_01.pdf
|
DR-XY48400
|
Indacaterol (as acetate) + Mometasone furoate
|
Atectura Breezhaler
|
150 mcg/ 320 mcg (equivalent to 125 mcg/ 260 mcg
delivered dose)
|
Powder for Inhalation in Hard Capsule
|
Adrenergic-Corticosteroid Combination
|
Novartis Pharma Stein AG
|
Switzerland
|
Monitored Release
|
07 October 2022
|
07 October 2027
|
| View |
|
DR-XY48386
|
Montelukast (As Sodium)
|
Maura Kids
|
5 mg
|
Chewable Tablet
|
Leukotriene Receptor Antagonist
|
Kusum Healthcare Pvt. Ltd.
|
India
|
Initial
|
30 September 2022
|
30 September 2027
|
| View |
|
DR-XY48385
|
Montelukast (as Sodium)
|
Maura Kids
|
4 mg
|
Chewable Tablet
|
Leukotriene Receptor Antagonist
|
Kusum Healthcare Pvt. Ltd.
|
India
|
Initial
|
30 September 2022
|
30 September 2027
|
| View |
|
DRP-12751
|
Pregabalin
|
None
|
100 mg
|
Capsule
|
Antiepileptic
|
Phil. United Pharma Corp.
|
Philippines
|
Initial
|
03 October 2022
|
03 October 2027
|
| View |
|
DR-XY48351
|
Oxycodone hydrochloride
|
Oxymarc
|
20 mg/2 mL
|
Solution for Injection/Infusion (I.V./S.C.)
|
Opioid Analgesic
|
HBM Pharma S.R.O.
|
Slovak Republic
|
Initial (Correction)
|
02 May 2023
|
06 October 2027
|