| View |
|
DR-XY48118
|
Escitalopram (as Oxalate)
|
Depram
|
10 mg
|
Film Coated Tablet
|
Antidepressant (Selective Serotonin Reuptake Inhibitor)
|
PT. Novell Pharmaceutical Laboratories
|
Indonesia
|
Initial
|
22 June 2022
|
22 June 2027
|
| View |
|
DR-XY48119
|
Montelukast (as sodium) + Levocetirizine Hydrochloride
|
Zykast
|
10 mg/ 5 mg
|
Tablet
|
Leukotriene Receptor Antagonist/ Antihistamine
|
Ajanta Pharma Limited
|
India
|
Initial
|
21 June 2022
|
21 June 2027
|
| View |
|
DR-XY48120
|
Olmesartan medoxomil + Hydrochlorothiazide
|
Alzor HCT
|
40mg/12.5mg
|
Film-Coated Tablet
|
-
|
Ajanta Pharma Limited
|
India
|
Initial
|
21 June 2022
|
21 June 2027
|
| View |
|
DR-XY48121
|
Olmesartan medoxomil + Hydrochlorothiazide
|
Alzor HCT
|
20mg/ 12.5mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker/Diuretic
|
Ajanta Pharma Limited
|
India
|
Initial
|
21 June 2022
|
21 June 2027
|
| View |
|
DR-XY48122
|
Ertapenem (as sodium)
|
Ertapen
|
1 g
|
Lyophilized Powder for Injection (I.V.)
|
Antibacterial (Carbapenem)
|
Savior Lifetec Corporation (Tainan Branch Injection Plant)
|
Taiwan
|
Initial
|
21 June 2022
|
21 June 2027
|
| View |
|
DR-XY48123
|
Topiramate
|
Trokendi XR
|
200 mg
|
Extended Release Capsule
|
-
|
Orient Pharma Co., Ltd.
|
Taiwan
|
Monitored Release
|
21 June 2022
|
21 June 2025
|
| View |
|
DR-XY48124
|
Remifentanil (as hydrochloride)
|
None
|
2 mg
|
Lyophilized Powder for Solution for Injection or Infusion (IV)
|
Opioid Analgesic
|
Laboratorios Normon, S.A.
|
Spain
|
Initial
|
21 June 2022
|
21 June 2027
|
| View |
|
DR-XY48125
|
Remifentanil (as hydrochloride)
|
None
|
5 mg
|
Lyophilized Powder for Solution for Injection or Infusion (IV)
|
Opioid Anaesthetic
|
Laboratorios Normon, S.A.
|
Spain
|
Initial
|
21 June 2022
|
21 June 2027
|
| View |
|
DR-XY48126
|
Topiramate
|
Trokendi XR
|
200 mg
|
Extended Release Capsule
|
Antiepileptic
|
Orient Pharma Co., Ltd.
|
Taiwan
|
Monitored Release
|
21 June 2022
|
21 June 2025
|
| View |
DR-XY48127_PI_01.pdf
|
DR-XY48127
|
Tadalafil + Tamsulosin hydrochloride
|
Gugutams
|
5 mg/400 mcg
|
Capsule [contains one (1) Film-Coated Tadalafil and Tamsulosin HCl pellets]
|
Alpha-adrenoreceptor Antagonist
|
Hanmi Pharmaceutical Co., Ltd.
|
Korea
|
Monitored Release (MR)
|
21 June 2022
|
21 June 2027
|
| View |
DR-XY48128_PI_01.pdf
|
DR-XY48128
|
Famciclovir
|
Penvir 750
|
750mg
|
Film Coated Tablet
|
Antiviral (Nucleoside/nucleotide excl. reverse transcriptase inhibitor)
|
Hetero Labs Limited (Unit V)
|
India
|
Monitored Release (MR) (Correction)
|
27 February 2024
|
21 June 2025
|
| View |
|
DR-XY48129
|
Topiramate
|
Trokendi XR
|
100 mg
|
Extended Release Capsule
|
Antiepileptic
|
Orient Pharma Co., Ltd.
|
Taiwan
|
Monitored Release
|
22 June 2022
|
22 June 2025
|
| View |
|
DR-XY48130
|
Topiramate
|
Trokendi XR
|
100 mg
|
Extended Release Capsule
|
-
|
Orient Pharma Co., Ltd.
|
Taiwan
|
Monitored Release
|
22 June 2022
|
22 June 2025
|
| View |
|
DR-XY48131
|
Ceftazidime (As Pentahydrate)
|
Ceftadime
|
1 g
|
Powder for Injection (IM/IV)
|
Antibacterial (Third-generation cephalosporin)
|
Scott-Edil Advance Research Laboratories & Education Limited
|
India
|
Initial
|
01 July 2022
|
01 July 2027
|
| View |
|
DR-XY48132
|
Tadalafil + Tamsulosin Hydrochloride
|
Duactam
|
5mg/400mcg
|
Capsule
|
Alpha-Adrenorecptor Antagonist
|
Ajanta Pharma Limited
|
India
|
Monitored Release (Re-application)
|
23 June 2022
|
23 June 2027
|
| View |
|
DR-XY48133
|
Topiramate
|
Trokendi XR
|
25 mg
|
Extended Release Capsule
|
-
|
Orient Pharma Co., Ltd.
|
Taiwan
|
Monitored Release
|
23 June 2022
|
23 June 2025
|
| View |
|
DR-XY48134
|
Topiramate
|
Trokendi XR
|
25 mg
|
Extended Release Capsule
|
Antiepileptic
|
Orient Pharma Co., Ltd.
|
Taiwan
|
Monitored Release
|
23 June 2022
|
23 June 2025
|
| View |
|
DR-XY48135
|
Azathioprine
|
Imuran
|
50 mg
|
Tablet
|
Immunosuppressant
|
Aspen SA Operations (Pty) Ltd.
|
Africa
|
Initial
|
24 June 2022
|
24 June 2027
|
| View |
|
DR-XY48136
|
Rosuvastatin (as calcium)
|
Rosucol
|
5 mg
|
Film-Coated Tablet
|
HMG COA Reductase Inhibitor
|
Ajanta Pharma Limited
|
India
|
Initial
|
27 June 2022
|
27 June 2027
|
| View |
DR-XY48137_PI_01.pdf
|
DR-XY48137
|
Abrocitinib
|
Cibinqo
|
100 mg
|
Film-coated Tablet
|
-
|
Pfizer Manufacturing Deutschland GmbH
|
Germany
|
Monitored Release
|
27 June 2022
|
27 June 2027
|