| View |
|
DRP-14086
|
Methylprednisolone (as sodium succinate)
|
Philsolon
|
40mg
|
Lyophilized Powder For Injection (I. M./I.V.)
|
-
|
Fuan Pharmaceutical
Pharmaceutical Co., Ltd.
|
China
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
DR-XY48452
|
Remimazolam
|
Byfavo
|
50mg
|
Lyophilized Powder for Intravenous Infusion
|
-
|
Hana Pharmaceutical Co., Ltd.
|
Korea
|
Reapplication
|
04 July 2023
|
04 July 2028
|
| View |
|
DRP-14140
|
Cefazolin (as Sodium)
|
Novazolin
|
500mg
|
Powder for Injection (IM/IV)
|
-
|
Swiss Parenterals Ltd.
|
India
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
DRP-14142
|
Montelukast (as Sodium)
|
Monspire 4
|
4 mg
|
Chewable Tablet
|
-
|
Aurobindo Pharma Limited (Unit VII)
|
India
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
DRP-14132
|
Irbesartan + Hydrochlorothiazide
|
Co-Irda
|
300mg/25mg
|
Film Coated Tablet
|
-
|
Nobel İlaç Sanayíí ve Ticaret A.Ş.
|
Turkey
|
Initial
|
29 June 2023
|
29 June 2028
|
| View |
|
DRP-14141
|
Cefuroxim (as sodium)
|
Cefrime 750
|
750 mg
|
Powder For Injection (IM/IV)
|
-
|
Swiss Parenterals Limited
|
India
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
DR-XY48791
|
Gabapentin
|
Gabafast
|
300 mg
|
Capsule
|
-
|
Kusum Healthcare Pvt. Ltd.
|
India
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
DRP-14134
|
Carmellose sodium
|
Optifrresh Gel
|
10 mg/mL (1% w/v)
|
Ophthalmic Solution (Eye drops)
|
-
|
Indiana Ophthalmics
|
India
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
DRP-14143
|
Gliclazide
|
Glycenil Mr 60
|
60 mg
|
Modified Release Tablet
|
-
|
Unison Laboratories Co., Ltd.
|
Thailand
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
DRP-14145
|
Diazepam
|
Anxiep
|
5 mg
|
Tablet
|
-
|
Akciju Sabiedrība "Grindeks" (Site I)
|
Latvia
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
DRP-14139
|
Telmisartan + Hydrochlorothiazide
|
None
|
40 mg/12.5 mg
|
Tablet
|
-
|
Intas Pharmaceuticals Limited
|
India
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
DR-XY48804
|
Racecadotril
|
Rasec
|
10 mg
|
Granules For Oral Solution
|
-
|
Athena Drug Delivery Solutions Pvt. Ltd.
|
India
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
DRP-14133
|
Co - Amoxiclav
|
Philclav DS
|
457 mg/5 mL
|
Powder for Oral Suspension
|
-
|
Giyaan Pharma Private Limited
|
India
|
Initial
|
29 June 2023
|
29 June 2028
|
| View |
|
DRP-14144
|
Clonidine Hydrochloride
|
None
|
150mcg
|
Tablet
|
-
|
Drugmaker's Laboratories, Inc.
|
Philippines
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
DRP-14154
|
Gliclazide
|
Glubitor-Od
|
30 mg
|
Sustained-Release Tablet
|
-
|
Amherst Laboratories, Inc.
|
Philippines
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
DR-XY48797
|
Fluticasone Furoate
|
Avamys
|
27.5 mcg/actuation
|
Suspension for Nasal Spray
|
-
|
Glaxo Wellcome S.A
|
Spain
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
DR-XY48795
|
Rivaroxaban
|
Xafariv 20
|
20 mg
|
Film-Coated Tablet
|
-
|
Mylan Laboratories Limited
|
India
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
DR-XY48803
|
Racecadotril
|
Rasec
|
30 mg
|
Granules for Oral Solution
|
-
|
Athena Drug Delivery Solutions Pvt. Ltd.
|
India
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
DRP-14155
|
Valaciclovir (As Hydrochloride)
|
None
|
500 mg
|
Film-Coated Tablet
|
-
|
Aurobindo Pharma Limited (Unit III)
|
India
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
DRP-14135
|
Pantoprazole as Sodium)
|
Zerocid
|
40mg
|
Lyophilized Powder For Injection
|
-
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
30 June 2023
|
30 June 2028
|