| View |
|
DR-XY48898
|
Sonidegib (as phosphate)
|
Odomzo
|
200 mg
|
Capsule
|
Antineoplastic Agent (Hedgehog Pathway Inhibitor)
|
Patheon Inc.
|
Canada
|
Monitored Release (Reconstruction)
|
31 July 2024
|
05 October 2028
|
| View |
|
DR-XY48899
|
Co Amoxiclav
|
Claxon
|
156.25 mg/5 mL
|
Powder for Oral Suspension
|
-
|
Medopharm Private Limited
|
India
|
Initial
|
16 October 2023
|
05 October 2028
|
| View |
|
DR-XY48900
|
Levosalbutamol (as tartrate)
|
Airlevo
|
45 mcg per Actuation Inhalation
(200 actuations)
|
Actuation Inhalation
|
-
|
Glenmark Pharmaceuticals Limited
|
India
|
Monitored Release
|
11 October 2023
|
11 October 2028
|
| View |
|
DR-XY48901
|
Cefotaxime (as sodium)
|
Nexatine
|
1 g
|
Powder for Injection (IM/IV)
|
-
|
Vellinton Healthcare
|
India
|
Initial
|
16 October 2023
|
16 October 2028
|
| View |
DR-XY48902_PI_01.pdf
|
DR-XY48902
|
Asciminib (as hydrochloride)
|
Bacrelba
|
40 mg
|
Film-Coated Tablet
|
-
|
Novartis Pharma Stein AG
|
Switzerland
|
Monitored Release
|
19 October 2023
|
19 October 2028
|
| View |
DR-XY48903_PI_01.pdf
|
DR-XY48903
|
Asciminib (as hydrochloride)
|
Bacrelba
|
20 mg
|
Film-Coated Tablet
|
-
|
Novartis Pharma Stein AG
|
Switzerland
|
Monitored Release
|
19 October 2023
|
19 October 2028
|
| View |
|
DR-XY48904
|
Dapsone
|
None
|
75 mg/g (7.5% w/w)
|
Topical Gel
|
-
|
Encube Ethicals Pvt. Ltd.
|
India
|
Monitored Release
|
20 October 2023
|
20 October 2028
|
| View |
|
DR-XY48905
|
Ranitidine (as hydrochloride)
|
Ranigerd
|
25 mg/mL (50 mg/2 mL)
|
Solution for Injection (I.M./I.V.)
|
-
|
Zee Laboratories Limited
|
India
|
Initial
|
20 October 2023
|
20 October 2028
|
| View |
DR-XY48906_PI_01.pdf
|
DR-XY48906
|
Palbociclib
|
Ibrance
|
75 mg
|
Film-Coated Tablet
|
-
|
Pfizer Manufacturing Deutschland GmbH
|
Germany
|
Monitored Release
|
20 October 2023
|
20 October 2028
|
| View |
DR-XY48907_PI_01.pdf
|
DR-XY48907
|
Palbociclib
|
Ibrance
|
100 mg
|
Film-Coated Tablet
|
-
|
Pfizer Manufacturing Deutschland GmbH
|
Germany
|
Monitored Release (MR)
|
20 October 2023
|
20 October 2028
|
| View |
DR-XY48908_PI_01.pdf
|
DR-XY48908
|
Palbociclib
|
Ibrance
|
125 mg
|
Film-Coated Tablet
|
-
|
Pfizer Manufacturing Deutschland GmbH
|
Germany
|
Monitored Release (MR)
|
20 October 2023
|
20 October 2028
|
| View |
|
DR-XY48909
|
Apixaban
|
Axasoar 5
|
5 mg
|
Film-Coated Tablet
|
-
|
USV Private Limited
|
India
|
Initial
|
23 October 2023
|
23 October 2028
|
| View |
|
DR-XY48910
|
Apixaban
|
Axasoar 2.5
|
2.5 mg
|
Film-Coated Tablet
|
-
|
USV Private Limited
|
India
|
Initial
|
23 October 2023
|
23 October 2028
|
| View |
|
DR-XY48911
|
Paracetamol
|
Tempra Blizz
|
500 mg
|
Effervescent Tablet (Orange Flavor)
|
-
|
DHG Pharmaceutical Joint-Stock Company
|
Vietnam
|
Initial [OTC]
|
26 October 2023
|
26 October 2028
|
| View |
|
DR-XY48912
|
Bisoprolol fumarate
|
Epibloc
|
5 mg
|
Film-Coated Tablet
|
-
|
ACME Formulation Pvt. Ltd.
|
India
|
Initial
|
27 October 2023
|
27 October 2028
|
| View |
|
DR-XY48913
|
Benzydamine hydrochloride + Cetylpyridinium chloride
|
Orawell
|
1.5 mg/5 mg
|
Oromucosal Spray Solution
|
Non-steroidal anti-inflammatory/Antiseptic
|
KRKA, D.D., Novo Mesto
|
Slovenia
|
Monitored Release (Correction)
|
09 May 2024
|
07 November 2028
|
| View |
|
DR-XY48914
|
Cefoxitin (as sodium)
|
Trexin
|
1 g
|
Powder for Injection (IV)
|
-
|
Vellinton Healthcare
|
India
|
Initial
|
09 November 2023
|
09 November 2028
|
| View |
|
DR-XY48915
|
Cefuroxime (as sodium)
|
Shamcef-1500
|
1.5 g
|
Powder for Injection (IM/IV)
|
-
|
Shamshree Lifesciences Ltd.
|
India
|
Initial
|
09 November 2023
|
09 November 2028
|
| View |
|
DR-XY48916
|
Cefuroxime (as sodium)
|
Shamcef-750
|
750 mg
|
Powder for Injection (I.V.)
|
-
|
Shamshree Lifesciences Ltd.
|
India
|
Initial
|
09 November 2023
|
09 November 2028
|
| View |
|
DR-XY48917
|
Tegafur Gimeracil + Oteracil potassium
|
S-1 25
|
25 mg/7.25 mg/24.5 mg
|
Capsule
|
-
|
Taiho Pharmaceutical Co., Ltd.
|
Japan
|
Monitored Release
|
15 November 2023
|
15 November 2028
|