| View |
|
DR-XY48752
|
Lacosamide
|
Acode 50
|
50mg
|
Film-Coated Tablet
|
-
|
Torrent Pharmaceuticals Ltd. (Baddi Plant)
|
India
|
Monitored Release
|
31 May 2023
|
31 May 2028
|
| View |
|
DR-XY48753
|
Lacosamide
|
Acode 150
|
150mg
|
Film-Coated Tablet
|
-
|
Torrent Pharmaceuticals Ltd. (Baddi Plant)
|
India
|
Monitored Release
|
31 May 2023
|
31 May 2028
|
| View |
|
DR-XY48754
|
Lacosamide
|
Acode 200
|
200mg
|
Film-Coated Tablet
|
-
|
Torrent Pharmaceuticals Ltd. (Baddi Plant)
|
India
|
Monitored Release
|
31 May 2023
|
31 May 2028
|
| View |
|
DR-XY48755
|
Clobetasol Propionate
|
Clobetor
|
500 mcg/g
|
Cream
|
-
|
Torrent Pharmaceuticals Limited
|
India
|
Initial
|
30 May 2023
|
30 May 2028
|
| View |
|
DR-XY48756
|
Desvenlafaxine (As succinate monohydrate)
|
Devert-100
|
100 mg
|
Controlled-Release Tablet
|
-
|
Torrent Pharmaceuticals Ltd. (Baddi Plant)
|
India
|
Monitored Release (MR) (Correction)
|
02 August 2023
|
01 June 2028
|
| View |
|
DR-XY48757
|
Desvenlafaxine (as succinate monohydrate)
|
Devert-50
|
50 mg
|
Controlled-Release Tablet
|
-
|
Torrent Pharmaceuticals Ltd. (Baddi Plant)
|
India
|
Monitored Release (MR)
|
01 June 2023
|
01 June 2028
|
| View |
|
DR-XY48758
|
Vancomycin (as hydrochloride)
|
Vansafe-CP
|
1 g
|
Powder For Injection (I.V.)
|
-
|
VHB Medi Sciences Limited
|
India
|
Initial
|
01 June 2023
|
01 June 2028
|
| View |
|
DR-XY48759
|
Dopamine Hydrochloride
|
Duomine
|
40mg/mL (200mg /5mL)
|
Solution for Injection (I.V.)
|
-
|
Duopharma (M) Sdn. Bhd.
|
Malaysia
|
Initial
|
06 June 2023
|
06 June 2028
|
| View |
|
DR-XY48760
|
Olmesartan Medoxomil
|
Alzor
|
40mg
|
Film-Coated Tablet
|
-
|
Ajanta Pharma Limited
|
India
|
Initial
|
06 June 2023
|
06 June 2028
|
| View |
|
DR-XY48761
|
Olmesartan Medoxomil
|
Alzor
|
20mg
|
Film-Coated Tablet
|
-
|
Ajanta Pharma Limited
|
India
|
Initial
|
06 June 2023
|
06 June 2028
|
| View |
|
DR-XY48762
|
Fluconazole
|
Fluczan
|
200mg
|
Capsule
|
-
|
Siam Bheasach Co., Ltd.
|
Thailand
|
Initial
|
06 June 2023
|
06 June 2028
|
| View |
|
DR-XY48764
|
Aciclovir
|
Zoylex
|
25mg/mL (250mg/10mL)
|
Solution for IV Infusion
|
-
|
Korea United Pharm. Inc.
|
Korea
|
Initial
|
06 June 2023
|
06 June 2028
|
| View |
|
DR-XY48765
|
Atorvastatin (as calcium trihydrate)
|
Crystorvas
|
20mg
|
Film-Coated Tablet
|
-
|
Duopharma Manufacturing (Bangi) Sdn. Bhd.
|
Malaysia
|
Initial
|
06 June 2023
|
06 June 2028
|
| View |
|
DR-XY48766
|
Atorvastatin (as calcium trihydrate)
|
Crystorvas
|
40mg
|
Film-Coated Tablet
|
-
|
Duopharma Manufacturing (Bangi) Sdn. Bhd.
|
Malaysia
|
Initial
|
06 June 2023
|
06 June 2028
|
| View |
|
DR-XY48767
|
Etoricoxib
|
Ercoxib 30
|
30 mg
|
Film-Coated Tablet
|
-
|
Unison Laboratories Co., Ltd.
|
Thailand
|
Initial
|
08 June 2023
|
08 June 2028
|
| View |
|
DR-XY48768
|
Tioconazole + Tinidazole
|
Tiotin
|
100 mg/ 150 mg
|
Vaginal Soft Gel capsule
|
-
|
Gelnova Laboratories (India) Pvt. Ltd.
|
India
|
Initial
|
08 June 2023
|
08 June 2028
|
| View |
|
DR-XY48769
|
Cisatracurium ( As Besilate)
|
Nimbex
|
2 mg/mL
|
Solution for Injcetion (IV)
|
-
|
Aspen SVP (Pty) Ltd.
|
South Africa
|
Initial
|
08 June 2023
|
08 June 2028
|
| View |
|
DR-XY48770
|
Tramadol Hydrochloride + Paracetamol
|
Dolcet Mini
|
18.75/162.50 mg
|
Film-Coated Tablet
|
-
|
Handok Inc.
|
Korea
|
Initial
|
09 June 2023
|
09 June 2028
|
| View |
DR-XY48771_PI_01.pdf
|
DR-XY48771
|
Budesonide/Glycopyrronium (as bromide)/
Formoterol fumarate (as dihydrate)
|
Breztri Aerosphere
|
160 mcg/7.2 mcg/4.8 mcg per actuation
|
Pressurized Metered-Dose Suspension for Inhalation
|
-
|
AstraZeneca Dunkerque Production.
|
France
|
Monitored Release
|
09 June 2023
|
09 June 2028
|
| View |
DR-XY48772_PI_01.pdf
|
DR-XY48772
|
Silodosin
|
Ureleve
|
4mg
|
Capsule
|
-
|
Ajanta Pharma Limited
|
India
|
Monitored Release
|
09 June 2023
|
09 June 2028
|