| View |
|
DR-XY48222
|
Sugammadex (As Sodium)
|
None
|
100 mg/mL (200 mg/ 2 mL)
|
Solution For Injection (IV)
|
Antidote
|
USV Private Limited
|
India
|
Initial
|
25 July 2022
|
25 July 2027
|
| View |
DR-XY48223_PI_01.pdf
|
DR-XY48223
|
Edaravone
|
Conjuvon
|
30mg/20mL
|
Solution for IV Infusion
|
Nervous System Drug
|
Simcere Pharmaceutical Co., Ltd.
|
China
|
Monitored Release
|
26 July 2022
|
26 July 2027
|
| View |
DR-XY48224_PI_01.pdf
|
DR-XY48224
|
Neostigmine Methylsulfate
|
Neostin 10
|
1 mg/mL (10 mg/10 mL)
|
Solution for Injection (I.M./I.V./S.C.)
|
-
|
Aspiro Pharma Limited
|
India
|
Monitored Release (Correction)
|
31 August 2022
|
26 July 2027
|
| View |
|
DR-XY48225
|
Levetiracetam
|
Levitra
|
1 g
|
Film Coated Tablet
|
Antiepileptic
|
Micro Labs Limited
|
India
|
Initial
|
26 July 2022
|
26 July 2027
|
| View |
|
DR-XY48226
|
Ranolazine
|
Razine
|
500mg
|
Extended-Release Tablet
|
Anti-Angina
|
Ajanta Pharma Limited
|
India
|
Initial [correctio]
|
22 August 2022
|
26 July 2027
|
| View |
|
DR-XY48227
|
Montelukast (as Sodium) + Levocetirizine Hydrochloride
|
Co-Altria
|
10mg/5mg
|
Tablet
|
Leukotriene Receptor Antagonist/ Antihistamine
|
Ajanta Pharma Limited
|
India
|
Initial (Correction
|
22 August 2022
|
26 July 2027
|
| View |
|
DR-XY48228
|
Ciprofloxacin (As Lactate)
|
Ciprobay
|
2 mg/mL
|
Solution for Intravenous (IV) Infusion
|
Antibacterial (Fluroquinolone)
|
Fresenius Kabi Italia S.R.L.
|
Italy
|
Initial (Correction)
|
30 July 2024
|
26 July 2027
|
| View |
|
DR-XY48229
|
Isosorbide Mononitrate
|
Vasotrate-120 OD
|
120 mg
|
Extended-Release Tablet
|
Vasodilator (Anti-angina)
|
Torrent Pharmaceuticals, Ltd.
|
India
|
Monitored Release (MR)
|
26 July 2022
|
26 July 2027
|
| View |
|
DR-XY48230
|
Topiramate
|
Trokendi XR
|
50 mg
|
Extended Release Capsule
|
Antiepileptic
|
Orient Pharma Co., Ltd.
|
Taiwan
|
Monitored Release
|
26 July 2022
|
26 July 2025
|
| View |
|
DR-XY48231
|
Topiramate
|
Trokendi XR
|
20 mg
|
Extended Release Capsule
|
Antiepileptic
|
Orient Pharma Co., Ltd.
|
Taiwan
|
Monitored Release
|
27 July 2022
|
27 July 2025
|
| View |
|
DR-XY48232
|
Rosuvastatin (as calcium) + Fenofibrate
|
Rosalfen
|
10 mg/160 mg
|
Film-Coated Tablet
|
Lipid Modifying Agents (HMG COA Reductase Inhibitor/ Fibrate
|
Ajanta Pharma Limited
|
India
|
Monitored Release
|
22 August 2022
|
27 July 2027
|
| View |
|
DR-XY48233
|
Sodium Hyaluronate
|
Osflex
|
25 mg/2.5 mL (10 mg/mL)
|
Solution for Injection in
Prefilled Syringe
|
Anti-Rheumatoid
|
PT. Novell Pharmaceutical Laboratories
|
Indonesia
|
Monitored Release
|
27 July 2022
|
27 July 2027
|
| View |
|
DR-XY48234
|
Rosuvastatin (As Calcium + Fenofibrate
|
Rosufen
|
20 mg/160 mg
|
Film-Coated Tablet
|
Lipid Modifying Agent, Combination
|
Ajanta Pharma Limited
|
India
|
Monitored Release
|
27 July 2022
|
27 July 2027
|
| View |
|
DR-XY48235
|
Rosuvastatin (as calcium) + Fenofibrate
|
Rosufen
|
10 mg/160 mg
|
Film-Coated Tablet
|
Lipid Modifying Agent
|
Ajanta Pharma Limited
|
India
|
Initial (Variation)
|
27 July 2022
|
27 July 2027
|
| View |
DR-XY48236_PI_01.pdf
|
DR-XY48236
|
Capmatinib (As Hydrochloride)
|
Rahika
|
150 mg
|
Film-Coated Tablet
|
-
|
Novartis Pharma produktions GmbH
|
Germany
|
Monitored Release
|
29 July 2022
|
29 July 2027
|
| View |
DR-XY48237_PI_01.pdf
|
DR-XY48237
|
Capmatinib (As Hydrochloride)
|
Rahika
|
200 mg
|
Film-Coated Tablet
|
-
|
Novartis Pharma produktions GmbH
|
Germany
|
Monitored Release
|
29 July 2022
|
29 July 2027
|
| View |
|
DR-XY48242
|
Canagliflozin (as hemihydrate)
|
None
|
300 mg
|
Film-Coated Tablet
|
Blood Glucose Lowering Drug [Sodium-Glucose
Co-Transporter 2 (SGLT2) Inhibitor]
|
Lloyd Laboratories, Inc
|
Philippines
|
Monitored Release (Reconstruction)
|
22 April 2024
|
19 November 2024
|
| View |
|
DR-XY48243
|
Moxifloxacin (as hydrochloride) + Dexamethasone
phosphate (as sodium)
|
Milflox Dm
|
5 mg/1 mg per mL (0.5%/0.1% w/v)
|
Sterile
Ophthalmic Solution
|
Anti-infective-Corticosteroid Combination
|
Sun Pharmaceutical Industries Ltd.
|
India
|
Monitored Release (Reconstruction)
|
31 July 2024
|
10 December 2026
|
| View |
|
DR-XY48245
|
Pregabalin + Mecobalamin
|
Preg-M
|
75 mg/750 mcg
|
Capsule
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Monitored Release (Reconstruction)
|
19 October 2023
|
29 December 2024
|
| View |
|
DR-XY48246
|
Docetaxel
|
Belcytere
|
20 mg/mL (80 mg/4mL) (160 mg/8 mL)
|
Solution for
Injection (IV Infusion)
|
-
|
Biolyse Pharma Corporation
|
Canada
|
Initial (Re-application]
|
29 July 2022
|
29 July 2027
|