| View |
|
DR-XY48200
|
Febuxostat
|
Febutor - 80
|
80 mg
|
Film-Coated Tablet
|
-
|
Torrent Pharmaceuticals Ltd.
|
India
|
Initial
|
19 July 2022
|
19 July 2027
|
| View |
|
DR-XY48201
|
Febuxostat
|
Febutor-40
|
40 mg
|
Film-Coated Tablet
|
-
|
Torrent Pharmaceuticals Ltd.
|
India
|
Initial
|
20 July 2022
|
20 July 2027
|
| View |
|
DR-XY48202
|
Pantoprazole (As Sodium Sesquihydrate)
|
None
|
40 mg
|
Enteric-Coated Tablet
|
Proton Pump Inhibitor
|
Y.S.P. Industries (M) Sdn. Bhd.
|
Malaysia
|
Initial
|
18 July 2022
|
18 July 2027
|
| View |
|
DR-XY48203
|
Sugammadex (As Sodium)
|
None
|
100 mg/mL (200 mg/ 2 mL)
|
Solution For Injection (IV)
|
Antidote
|
USV Private Limited
|
India
|
Initial
|
18 July 2022
|
18 July 2027
|
| View |
|
DR-XY48204
|
Thiamine Mononitrate (Vitamin B1) + Pyridoxine HC1
(Vitamin B6) + Cyanocobalamin (Vitamin B12)
|
Ethneuron Forte
|
300 mg/ 100 mg/ 1000mcg
|
Tablet
|
Vitamins
|
Lejal Laboratories, Inc.
|
Philippines
|
Initial
|
20 July 2022
|
20 July 2027
|
| View |
|
DR-XY48206
|
Omeprazole (as sodium)
|
Omebloc
|
40 mg
|
Lyophilized Powder for Injection (I.V.)
|
Proton Pump Inhibitor
|
Zee Laboratories Limited
|
India
|
Initial
|
20 July 2022
|
20 July 2027
|
| View |
DR-XY48207_PI_01.pdf
|
DR-XY48207
|
Pomalidomide
|
Pomadex 4
|
4 mg
|
Capsule
|
Immunosuppressant
|
Hetero Labs Limited (Unit-V, Block-VB)
|
India
|
Monitored Release
|
20 July 2022
|
20 July 2025
|
| View |
DR-XY48208_PI_01.pdf
|
DR-XY48208
|
Pomalidomide
|
Pomadex 3
|
3 mg
|
Capsule
|
Immunosuppressant
|
Hetero Labs Limited (Unit-V, Block-VB)
|
India
|
Monitored Release
|
20 July 2022
|
20 July 2025
|
| View |
|
DR-XY48209
|
Diclofenac Sodium
|
Diclosafe
|
100 mg
|
Rectal Suppository
|
Non-steroid Antiinflammatory and Antirheumatic
Product
|
Kusum Healthcare Pvt. Ltd. (Block II)
|
India
|
Monitored Release
|
21 July 2022
|
21 July 2027
|
| View |
|
DR-XY4821
|
Vitamin B Complex + Inositol + Choline Bitartrate
|
Balanced B-100
|
Formulation: Each tablet contains:
Thiamine Mononitrate (Vitamin B1)-100mg Riboflavin (Vitamin B2)-100mg Niacinamide (Vitamin B3)-100mg Pyridoxine hydrochloride (Vitamin B6)-100 mg Calcium Pantothenate-100 mg
Inositol-100 mg Choline Bitartrate-45mg Folic Acid-400mcg Cyanocobalamin (Vitamin B12)-100mcg Biotin (Vitamin B7)-100mcg
|
Tablet
|
-
|
Nexgen Pharma, Inc.
|
United States of America
|
Initial
|
15 August 2022
|
15 August 2027
|
| View |
|
DR-XY48210
|
Levodropropizine
|
Levotic CR
|
90 mg
|
Controlled-Release Tablet
|
Cough Suppressant
|
Korea United Pharm. Inc.
|
Korea
|
Monitored Release (MR) (Re-application)
|
21 July 2022
|
21 July 2027
|
| View |
|
DR-XY48211
|
Imipenem +Cilastatin Sodium
|
Imiclast
|
500 mg/ 500 mg
|
Powder for Solution for Infusion (I.V.)
|
Antibacterial (Carbapenem)
|
PT. Novell Pharmaceutical Laboratories
|
Indonesia
|
Initial
|
22 July 2022
|
22 July 2027
|
| View |
|
DR-XY48212
|
Iohexol
|
Exovell
|
647 mg/mL (eq. to 300 mg/ mL of Iodine)
|
Solution for Injection (Intravenous/ Intra-arterial/
Intrathecal/ Body Cavities)
|
Non-Ionic Radiocontrast Media
|
PT. Novell Pharmaceutical Laboratories
|
Indonesia
|
Initial
|
22 July 2022
|
22 July 2027
|
| View |
|
DR-XY48213
|
Iohexol
|
Exovell
|
755 mg/ mL (eq. to 350 mg/ mL of Iodine)
|
Solution for Injection (Intravenous/ Intra-arterial/
Intrathecal/ Body Cavities)
|
Non-Ionic Radiocontrast Media
|
PT. Novell Pharmaceutical Laboratories
|
Indonesia
|
Initial
|
22 July 2022
|
22 July 2027
|
| View |
DR-XY48216_PI_01.pdf
|
DR-XY48216
|
Pomalidomide
|
Pomadex 1
|
1 mg
|
Capsule
|
Immunosuppressant
|
Hetero Labs Limited (Unit-V, Block-VB)
|
India
|
Monitored Release
|
21 July 2022
|
21 July 2025
|
| View |
DR-XY48217_PI_01.pdf
|
DR-XY48217
|
Pomalidomide
|
Pomadex 2
|
2 mg
|
Capsule
|
-
|
Hetero Labs Limited (Unit-V, Block-VB)
|
India
|
Monitored Release
|
21 July 2022
|
21 July 2025
|
| View |
|
DR-XY48218
|
Diquafosol sodium
|
Diquas-S
|
30 mg/mL (3% w/v)
|
Ophthalmic Solution
|
P2Y2 (Purinoceptor) Agonist
|
Huons Co., Ltd.
|
Korea
|
Monitored Release
|
21 July 2022
|
21 June 2027
|
| View |
|
DR-XY48219
|
Docetaxel
|
None
|
20 mg/mL (80 mg / 4 mL)
|
Concentrate For Solution For IV Infusion
|
Antineoplastic (Taxane)
|
Venus Remedies, Limited
|
India
|
Initial
|
22 July 2022
|
22 July 2027
|
| View |
DR-XY48220_PI_01.pdf
|
DR-XY48220
|
Budesonide + Formoterol Fumarate Dihydrate
|
Fortra
|
200 mcg/ 6 mcg per Actuation
|
Metered Dose Pressurized Inhalation Suspension
|
Adrenergic-Corticosteroid Combination
|
Getz Pharma Pvt. Ltd.
|
Pakistan
|
Monitored Release (Correction)
|
01 September 2022
|
25 July 2027
|
| View |
|
DR-XY48221
|
Ceftazidime
|
Eozidime-1000
|
1 g
|
Powder for Solution for Injection (I.M./1.V.)
|
Antibacterial (Cephalosporin)
|
Zee Laboratories Limited
|
India
|
Initial
|
25 July 2022
|
25 July 2027
|