| View |
|
DR-XY47889
|
Montelukast (as sodium) + Levocetirizine Hydrochloride
|
Co-Altria Ped
|
5mg/5mg
|
Chewable Tablet
|
Leukotriene Receptor Antagonist/Antihistamine
|
Ajanta Pharma Limited
|
India
|
Initial (from Monitored Release) [Reconstruction]
|
03 October 2022
|
01 April 2027
|
| View |
|
DR-XY47890
|
Montelukast (as sodium) + Levocetirizine hydrochloride
|
Co-Altria Ped
|
5mg/2.5mg
|
Chewable Tablet
|
Leukotriene Receptor Antagonist/Antihistamine
|
Ajanta Pharma Limited
|
India
|
Initial (from Monitored Release) [Reconstruction]
|
03 October 2022
|
01 April 2027
|
| View |
DR-XY47891_PI_01.pdf
|
DR-XY47891
|
Ledipasvir + Sofosbuvir
|
Qurled Lp
|
90 mg / 400 mg
|
Film-Coated Tablet
|
Antiviral Combination
|
Strides Shasun Limited
|
India
|
Monitored Release
|
04 April 2022
|
04 April 2027
|
| View |
DR-XY47892_PI_01.pdf
|
DR-XY47892
|
Metformin hydrochloride + Gliclazide + Pioglitazone
(as hydrochloride)
|
Trizeric
|
500 mg/80 mg/15 mg
|
Film-Coated Tablet
|
Oral Blood Glucose Lowering Drug Combination
|
Ajanta Pharma Limited
|
India
|
Monitored Release
|
04 April 2022
|
04 April 2027
|
| View |
DR-XY47893_PI_01.pdf
|
DR-XY47893
|
Tenofovir alafenamide (as fumarate)
|
Tafnat
|
25 mg
|
Film-Coated Tablet
|
Antiviral (Nucleoside/Nucleotide) Reverse Transcriptase Inhibitor)
|
Natco Pharma Limited
|
India
|
Monitored Release
|
04 April 2022
|
04 April 2027
|
| View |
|
DR-XY47894
|
Telmisartan
|
Ajesart
|
80 mg
|
Tablet
|
Angiotensin II Receptor Blocker
|
Actavis Ltd.
|
Malta
|
Initial
|
04 April 2022
|
04 April 2027
|
| View |
|
DR-XY478942
|
Telmisartan
|
Telatraz
|
40 mg
|
Tablet
|
-
|
Alembic Pharmaceuticals Limited
|
India
|
Initial
|
29 November 2023
|
29 November 2028
|
| View |
|
DR-XY47895
|
Telmisartan + Hydrochlorothiazide
|
Ajezide
|
80 mg/25 mg
|
Tablet
|
Angiotensin II Receptor Blocker- Diuretic Combination
|
Actavis Ltd.
|
Malta
|
Initial
|
04 April 2022
|
04 April 2027
|
| View |
|
DR-XY47896
|
Ascorbic Acid
|
None
|
500mg (equivalent to 562.43mg Sodium Ascorbate)
|
Capsule
|
Vitamin
|
Compact Pharmaceuticals, Corp.
|
Philippines
|
Initial
|
04 April 2022
|
04 April 2027
|
| View |
DR-XY47898_PI_01.pdf
|
DR-XY47898
|
Gemcitabine(as hydrochloride)
|
Gemcilex
|
200 mg
|
Lyophilized Powder for Injection (IV)
|
Antineoplastic (Pyrimidine analogues)
|
Laboratorio Kemex S.A.
|
Argentine Republic
|
Initial
|
04 April 2022
|
04 April 2027
|
| View |
|
DR-XY47899
|
Mupirocin
|
Mucin
|
20 mg/g (2% w/w)
|
Ointment
|
Antibacterial
|
Global Pharmaceuticals (Pvt.) Ltd.
|
Pakistan
|
Initial
|
04 April 2022
|
04 April 2027
|
| View |
|
DR-XY47900
|
Omeprazole (as sodium)
|
Omekhriz 40
|
40 mg
|
Lyophilized Powder for Injection (IV)
|
Proton Pump Inhibitor (PPI)
|
Reyoung Pharmaceutical Co., Ltd..
|
China
|
Initial (Reconstruction)
|
29 May 2024
|
05 April 2027
|
| View |
|
DR-XY47901
|
Rosuvastatin (as calcium)
|
Rosucol
|
20 mg
|
Film-Coated Tablet
|
HMG COA Reductase Inhibitor
|
Ajanta Pharma Limited
|
India
|
Initial
|
05 April 2022
|
05 April 2027
|
| View |
|
DR-XY47902
|
Rosuvastatin (as calcium)
|
Rosucol
|
10 mg
|
Film-Coated Tablet
|
HMG CoA Reductase Inhibitor
|
Ajanta Pharma Limited
|
India
|
Monitored Release
|
05 April 2022
|
05 April 2027
|
| View |
DR-XY47903_PI_01.pdf
|
DR-XY47903
|
Olmesartan Medoxomil) + Amlodipine (as besilate)
|
Alzor CCB
|
20 mg/5 mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blockers (ARBs) and Calcium
Channel Blockers
|
Ajanta Pharma Limited
|
India
|
Initial [from Monitored Release status] [Reconstruction]
|
22 December 2022
|
05 April 2027
|
| View |
DR-XY47904_PI_01.pdf
|
DR-XY47904
|
Olmesartan Medoxomil
|
Alzor
|
40 mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker
|
Ajanta Pharma Limited
|
India
|
Monitored Release
|
05 April 2022
|
05 April 2027
|
| View |
|
DR-XY47905
|
Rivaroxaban
|
Varoxa
|
20 mg
|
Film Coated Tablet
|
Antithrombotic Agent
|
Micro Labs Limited
|
India
|
Initial
|
07 April 2022
|
07 April 2027
|
| View |
|
DR-XY47906
|
Rivaroxaban
|
Varoxa
|
10 mg
|
Film Coated Tablet
|
-
|
Micro Labs Limited
|
India
|
-
|
07 April 2022
|
07 April 2027
|
| View |
|
DR-XY47907
|
Moxifloxacin hydrochloride
|
Moxiwar 400
|
400 mg
|
Film-Coated Tablet
|
Antibacterial
|
Aurobindo Pharma Limited-Unit VII
|
India
|
Initial
|
06 April 2022
|
06 April 2027
|
| View |
|
DR-XY47909
|
Salmeterol Xinafoate + Fluticasone Propionate
|
Respiro
|
25 mcg/125 mcg
|
Metered Dose Inhaler
|
Adrenergic / Corticosteroid
|
Deva Holding A.Ş.
|
Turkey
|
Initial
|
08 April 2022
|
08 April 2027
|