| View |
|
DR-XY48368
|
Paracetamol
|
Khrizgesic
|
500mg
|
Tablet
|
Analgesic/Antipyretic
|
Merit Organics Ltd.
|
India
|
Initial (OTC)
|
22 September 2022
|
22 September 2027
|
| View |
|
DR-XY48369
|
Paracetamol + Phenylephrine Hydrochloride (Day Tablet)
and Paracetamol + Phenylephrine Hydrochloride +
Chlorpheniramine Maleate (Night Tablet)
|
Sinutab Cold Day & Night
|
500mg/5mg Film-coated Tablet (Day Tablet);
500mg/5mg / 2mg Film-coated Tablet (Night Tablet)
|
Film-Coated Tablet
|
Analgesic/Antipyretic/Nasal Decongestant;
Analgesic/Antipyretic/Nasal Decongestant/Antihistamine
|
Probiotec Pharma Pty Limited
|
Australia
|
Initial (OTC) (Reapplication) (Reconstruction
|
18 January 2023
|
22 September 2027
|
| View |
|
DR-XY48370
|
Telmisartan + Hydrochlorothiazide
|
Telmi HCT
|
40mg/12.5mg
|
Tablet
|
Angiotensin II receptor blocker (ARB) and diuretic
|
Ajanta Pharma Limited
|
India
|
Initial
|
22 September 2022
|
22 September 2027
|
| View |
DR-XY48371_PI_01.pdf
|
DR-XY48371
|
Nilotinib (as hydrochloride dihydrate)
|
Nicmel 200
|
200mg
|
Capsules
|
Antineoplastic agent (BCR-ABL tyrosine kinase inhibitor)
|
Hetero Labs Limited (Unit V and Unit V-A)
|
India
|
Monitored Release (Re-application)
|
11 October 2022
|
11 October 2027
|
| View |
DR-XY48372_PI_01.pdf
|
DR-XY48372
|
Nilotinib (as hydrochloride dihydrate)
|
Nicmel 150
|
150mg
|
Capsules
|
Antineoplastic agent (BCR-ABL tyrosine kinase inhibitor)
|
Hetero Labs Limited (Unit V and Unit V-A)
|
India
|
Monitored Release (Re-application)
|
11 October 2022
|
11 October 2027
|
| View |
|
DR-XY48373
|
Tadalafil
|
Thafil 20
|
20mg
|
Orodispersible Film
|
-
|
Zim Laboratories Limited
|
India
|
Monitored Release
|
23 September 2022
|
23 September 2025
|
| View |
|
DR-XY48374
|
Calcium + Cholecalciferol
|
CALVIMIN
|
500 mg/ 400 IU
|
Film-Coated Tablet
|
Mineral/Vitamin
|
The Acme Laboratories Limited
|
Bangladesh
|
Initial (OTC)
|
23 September 2022
|
23 September 2027
|
| View |
|
DR-XY48375
|
Mannitol
|
None
|
100g/500mL
|
Solution for IV Infusion
|
Irrigating Solution
|
Shijiazhuang No. 4 Pharmaceutical Co., Ltd.
|
China
|
Initial
|
23 September 2022
|
23 September 2027
|
| View |
|
DR-XY48376
|
Paclitaxel
|
None
|
6 mg/mL (300 mg/50 mL)
|
Concentrate for Solution for IV
Infusion
|
Antineoplastic agent (Taxane)
|
Venus Remedies, Limited
|
India
|
Initial
|
28 September 2022
|
28 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-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-XY48380
|
Sertraline (as Hydrochloride)
|
Altruline
|
50mg
|
Film-Coated Tablet
|
Antidepressant (Selective Serotonin Reuptake Inhibitor)
|
Pfizer Manufacturing Deutschland GmbH
|
Germany
|
Initial
|
29 September 2022
|
29 September 2027
|
| View |
DR-XY48381_PI_01.pdf
|
DR-XY48381
|
Abrocitinib
|
Cibinqo
|
50 mg
|
Film-coated Tablet
|
Agent for Dermatitis (Janus Kinase Inhibitor)
|
Pfizer Manufacturing Deutschland GmbH
|
Germany
|
Monitored Release
|
30 September 2022
|
30 September 2027
|
| View |
|
DR-XY48382
|
Bupropion Hydrochloride + Naltrexone Hydrochloride
|
Contrave
|
90 mg/ 8 mg
|
Extended Release Tablet
|
Anti-Obesity Preparation
|
Patheon Inc.
|
Canada
|
Monitored Release
|
30 September 2022
|
30 September 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 |
|
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-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 |
|
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-XY48387_PI_01.pdf
|
DR-XY48387
|
Revefenacin
|
Yupelri
|
175mcg/3mL
|
Solution for Inhalation
|
Anticholinergic
|
The Ritedose Corporation
|
United States of America
|
Monitored Release
|
03 October 2022
|
03 October 2027
|