| View |
|
DR-XY48960
|
Eslicarbazepine (as acetate)
|
Excarb 600
|
600 mg
|
Tablet
|
Antiepileptic (Carboxamide Derivative)
|
TORRENT PHARMACEUTICALS LTD.
|
India
|
Monitored Release
|
22 December 2023
|
22 December 2028
|
| View |
|
DR-XY48961
|
Eslicarbazepine (as acetate)
|
Excarb 800
|
800 mg
|
Tablet
|
Antiepileptic (Carboxamide Derivative)
|
TORRENT PHARMACEUTICALS LTD.
|
India
|
Monitored Release
|
22 December 2023
|
22 December 2028
|
| View |
|
DR-XY48962
|
Paracetamol
|
None
|
10 mg/mL
|
Solution for Injection (IV)
|
-
|
Shijiazhuang No. 4 Pharmaceutical Co., Ltd.
|
China
|
Initial
|
22 December 2023
|
22 December 2028
|
| View |
|
DR-XY48963
|
Pentosan Polysulfate Sodium
|
Comfora
|
100 mg
|
Hard Gelatin Capsule
|
Urinary Analgesic and Anesthetic
|
Steril-Gene Life Sciences (P) Limited
|
India
|
Monitored Release
|
27 December 2023
|
27 December 2028
|
| View |
|
DR-XY48964
|
Diosmin + Hesperidin
|
Hemaway
|
450mg/50mg
|
Film-coated Tablet
|
Vasoprotective
|
Renata Limited
|
Bangladesh
|
Initial
|
27 December 2023
|
27 December 2028
|
| View |
|
DR-XY48967
|
Azithromycin (as dihydrate)
|
Romycin
|
200 mg/5 mL
|
Powder for Oral Suspension
|
Antibacterial (Macrolide)
|
The IBN SINA Pharmaceutical Industry Ltd.
|
Bangladesh
|
Initial
|
28 December 2023
|
28 December 2028
|
| View |
|
DR-XY48968
|
Ondansetron (as hydrochloride dihydrate)
|
Strobon
|
4mg / 5 mL
|
Oral Solution
|
-
|
Limited Liability Company "Kusum Pharm"
|
Ukraine
|
Monitored Release
|
28 December 2023
|
28 December 2028
|
| View |
|
DR-XY48969
|
Aciclovir
|
Klozivex
|
50 mg/g (5% w/w)
|
Topical Ointment
|
-
|
ENCUBE ETHICALS PVT. LTD.
|
India
|
Initial
|
02 January 2024
|
02 January 2029
|
| View |
|
DR-XY48970
|
Miconazole
|
Iconagel
|
20mg/g (2% w/w)
|
Oral Gel
|
-
|
The IBN SINA Pharmaceutical Industry Ltd.
|
Bangladesh
|
Initial
|
02 January 2024
|
02 January 2029
|
| View |
|
DR-XY48971
|
Phytomenadione
|
Hema-K
|
10 mg/mL
|
Solution for Injection (I.M./I.V.)
|
-
|
Ciron Drugs & Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
03 January 2024
|
03 January 2029
|
| View |
|
DR-XY48972
|
Ivabradine (as hydrochloride)
|
Garda
|
7.5 mg
|
Film-Coated Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
04 January 2024
|
04 January 2029
|
| View |
|
DR-XY48973
|
Ivabradine (as hydrochloride)
|
Garda
|
5 mg
|
Film-Coated Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
04 January 2024
|
04 January 2029
|
| View |
|
DR-XY48974
|
Roflumilast
|
Rolfutor 500
|
500 mcg
|
Tablet
|
Drug for Obstructive Airway Diseases
|
Torrent Pharmaceuticals Ltd.
|
India
|
Initial
|
11 January 2024
|
11 January 2029
|
| View |
|
DR-XY48975
|
Rosuvastatin (as calcium)
|
Rovastin
|
20 mg
|
Film-Coated Tablet
|
Lipid Modifying Agent (HMG CoA Reductase Inhibitor)
|
Hizon Laboratories, Inc.
|
Philippines
|
Initial
|
11 January 2024
|
11 January 2029
|
| View |
|
DR-XY48976
|
Dolutegravir (as sodium) + Lamivudine + Tenofovir
Disoproxil (as fumarate)
|
None
|
50 mg/300 mg/300 mg
|
Film-Coated Tablet
|
Direct Acting Antiviral
|
Aurobindo Pharma Limited -Unit X
|
India
|
Monitored release
|
10 January 2024
|
10 January 2029
|
| View |
|
DR-XY48977
|
Chloramphenicol (as sodium succinate)
|
Chlorbact 1gm
|
1 g
|
Powder For Injection (Iv)
|
-
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
15 January 2024
|
15 January 2029
|
| View |
|
DR-XY48978
|
Zinc
|
Orezinc
|
20 mg (equivalent to 54.90 mg Zinc Sulfate Monohydrate) per 5 mL
|
Oral Solution
|
-
|
PT. Novell Pharmaceutical Laboratories
|
Indonesia
|
Initial
|
17 January 2024
|
17 January 2029
|
| View |
|
DR-XY48979
|
Zinc Sulfate (as monohydrate)
|
None
|
56 mg (equivalent to 20 mg elemental Zinc)/5 mL
|
Syrup
|
-
|
La Croesus Pharma, Inc.
|
Philippines
|
Initial
|
17 January 2024
|
17 January 2029
|
| View |
|
DR-XY48980
|
Meropenem (as trihydrate)
|
None
|
500mgl
|
Powder for I.V Injection
|
-
|
Anfarm Hellas S.A
|
Greece
|
Initial
|
19 January 2024
|
19 January 2029
|
| View |
|
DR-XY48981
|
Pemetrexed (as disodium)
|
Cartrexed
|
500 mg
|
Lyophilized Powder for Injection.
(IV Infusion)
|
-
|
Shanghai Chemo Wanbang Biopharma Co. Ltd.
|
China
|
Initial
|
23 January 2024
|
23 January 2029
|