| View |
|
DR-XY48158
|
Dabigatran etexilate (as mesilate)
|
Dabitrin 75
|
75 mg
|
Capsule
|
Antithrombotic Agent (Direct Thrombin Inhibitor)
|
Hetero Labs Limited (Unit III)
|
India
|
Initial (Variation)
|
14 March 2024
|
14 March 2029
|
| View |
|
DR-XY48159
|
Ciprofloxacin
|
Ciclodin IV
|
2mg/mL (400mg/200mL)
|
Solution for IV Injection
|
Antibacterial (Fluoroquinolone)
|
HK inno.N Corporation
|
Korea
|
Initial (Reconstruction)
|
01 February 2024
|
28 June 2027
|
| View |
|
DR-XY48160
|
Cefepime (as hydrochloride)
|
Cephalex
|
1 g
|
Powder for Injection (IM/IV)
|
Antibacterial (Fourth-generation cephalosporin)
|
Swiss Parenterals Ltd.
|
India
|
Initial
|
20 July 2022
|
20 July 2027
|
| View |
|
DR-XY48161
|
Teicoplanin
|
Ticoray
|
400mg
|
Powder For Injection (IV/IM)
|
Antibacterial
|
Mylan Laboratories Limited (Sterile Products Division)
|
India
|
Initial
|
04 July 2022
|
04 July 2027
|
| View |
DR-XY48162_PI_01.pdf
|
DR-XY48162
|
Lorlatinib
|
Lorviqua
|
25 mg
|
Film-Coated Tablet
|
-
|
Pfizer Manufacturing Deutschland GmbH
|
Germany
|
Monitored Release
|
04 July 2022
|
04 July 2027
|
| View |
DR-XY48163_PI_01.pdf
|
DR-XY48163
|
Lorlatinib
|
Lorviqua
|
100 mg
|
Film-Coated Tablet
|
-
|
Pfizer Manufacturing Deutschland GmbH
|
Germany
|
Monitored Release
|
04 July 2022
|
04 July 2027
|
| View |
|
DR-XY48164
|
Ropinirole (as hydrochloride)
|
Kinetica
|
8 mg
|
Prolonged-Release Tablet
|
-
|
Krka, D.D., Novo Mesto
|
Slovenia
|
Monitored Release
|
04 July 2022
|
04 July 2025
|
| View |
|
DR-XY48165
|
Rifampicin + Isoniazid
|
None
|
75mg/ 50mg
|
Dispersible Tablet
|
-
|
Macleods Pharmaceuticals Limited
|
India
|
Monitored Release
|
05 July 2022
|
05 July 2027
|
| View |
|
DR-XY48166
|
Rifampicin + Isoniazid
|
None
|
75mg/ 50mg
|
Dispersible Tablet
|
-
|
Macleods Pharmaceuticals Limited
|
India
|
Monitored Release
|
05 July 2022
|
05 July 2027
|
| View |
|
DR-XY48167
|
Ticagrelor
|
Gretor 90
|
90 mg
|
Film-Coated Tablet
|
-
|
Torrent Pharmaceuticals Ltd.
|
India
|
Monitored Release
|
05 July 2022
|
05 July 2027
|
| View |
|
DR-XY48168
|
Ticagrelor
|
Gretor 60
|
60 mg
|
Film-Coated Tablet
|
-
|
Torrent Pharmaceuticals Ltd.
|
India
|
Monitored Release
|
05 July 2022
|
05 July 2027
|
| View |
|
DR-XY48169
|
Apixaban
|
None
|
2.5 mg
|
Film- Coated Tablet
|
Antithrombotic Agent (Direct Factor Xa Inhibitor)
|
Cadila Healthcare Limited
|
India
|
Initial
|
07 July 2022
|
07 July 2027
|
| View |
|
DR-XY48170
|
Apixaban
|
None
|
5 mg
|
Film- Coated Tablet
|
Antithrombotic Agent (Direct Factor Xa Inhibitor)
|
Cadila Healthcare Limited
|
India
|
Initial
|
08 July 2022
|
08 July 2027
|
| View |
|
DR-XY48171
|
Paracetamol
|
Reximol
|
150 mg/mL (300 mg/2mL)
|
Solution for Injection
(I.M./I.V.)
|
Analgesic/Antipyretic
|
Furen Pharmaceutical Group Co., Ltd.
|
China
|
Initial
|
07 July 2022
|
07 July 2027
|
| View |
|
DR-XY48172
|
Domperidone
|
Dosin
|
10 mg
|
Tablet
|
Propulsive
|
Taiwan Biotech Co., Ltd.
|
Taiwan
|
Initial
|
07 July 2022
|
07 July 2027
|
| View |
|
DR-XY48173
|
Amiodarone Hydrochloride
|
Eurythmic
|
50 mg/mL (150 mg/3 mL)
|
Concentrate Solution for Injection/Infusion (IV)
|
Anti-arrhythmic Agent
|
Troikaa Pharmaceuticals Ltd.
|
India
|
Initial (Correction)
|
10 August 2022
|
07 July 2027
|
| View |
|
DR-XY48174
|
Daclastavir (as dihydrochloride)
|
Dacihep 60
|
60 mg
|
Film Coated Tablet
|
Direct-Acting Antiviral
|
Cadila Healthcare Limited
|
India
|
Monitored Release
|
07 July 2022
|
07 July 2027
|
| View |
|
DR-XY48175
|
Vinorelbine (as tartrate)
|
Vinobin
|
20 mg
|
Softgel Capsule
|
Antineoplastic Agent (Vinca Alkaloid/Analogue)
|
Lotus Pharmaceutical Co., Ltd (Nantou Plant)
|
Taiwan
|
Initial
|
08 July 2022
|
08 July 2027
|
| View |
|
DR-XY48177
|
Bisoprolol Fumarate
|
Bisocor
|
2.5 mg
|
Tablet
|
Beta blocking agents, Selective
|
Y.S.P. Industries (M) Sdn. Bhd.
|
Malaysia
|
Initial
|
11 July 2022
|
11 July 2027
|
| View |
|
DR-XY48178
|
Metformin Hydrochloride + Gliclazide
|
Glyzeric
|
500 mg/80 mg
|
Film-Coated Tablet
|
-
|
Ajanta Pharma Limited
|
India
|
Initial
|
11 July 2022
|
11 July 2027
|