| View |
|
DR-XY48559
|
Dobutamine (as hydrochloride)
|
Dobutafres
|
50 mg/mL
|
Solution for IV Infusion
|
-
|
PT. Ethica Industri Farmasi (PT. Ethica)
|
Indonesia
|
Initial
|
06 January 2023
|
06 January 2028
|
| View |
|
DRP-13218
|
Ceftriaxone(As Sodium)
|
Striaxon
|
1 g
|
Powder for Injection (IM/IV)
|
-
|
NCPC Hebei Huamin Pharmaceutical Company Limited
|
China
|
Initial
|
03 January 2023
|
03 January 2028
|
| View |
|
DR-XY48558
|
Vildagliptin
|
Vilget
|
50mg
|
Tablet
|
-
|
Getz Pharma Pvt. Ltd.
|
Pakistan
|
Initial
|
06 January 2023
|
06 January 2028
|
| View |
|
DRP-13225
|
Ketorolac Trometamol
|
Labtablock
|
30 mg/mL
|
Solution for Injection (IM/IV)
|
-
|
Akums Drugs & Pharmaceuticals Ltd. (Plant III
Injectables)
|
India
|
Initial
|
05 January 2023
|
05 January 2028
|
| View |
|
DRP-13217
|
Clobetasol (As Propionate)
|
Ecmetrix
|
500 mcg/g
|
Cream
|
-
|
Interphil Laboratories, Inc.
|
Philippines
|
Initial
|
03 January 2023
|
03 January 2028
|
| View |
|
DRP-13220
|
Clobetasol Propionate
|
Ecmetrix
|
500 mcg/g
|
Topical Ointment
|
-
|
Interphil Laboratories, Inc.
|
Philippines
|
Initial
|
03 January 2023
|
03 January 2028
|
| View |
|
DRP-13195
|
Zoledronic Acid (as monohydrate)
|
Saphdronic
|
4mg
|
Lyophilized Powder for IV Infusion
|
-
|
Bruck Pharma Private Limited
|
India
|
Initial
|
06 January 2023
|
06 January 2028
|
| View |
|
DRP-13232
|
Azithromycin (as dihydrate)
|
Azythrex
|
500 mg
|
Film Coated Tablet
|
-
|
Akriti Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
05 January 2023
|
05 January 2028
|
| View |
|
DRP-13244
|
Betamethasone (as dipropionate) + Clotrimazole +
Gentamicin (as sulfate)
|
Genclobet
|
500 mcg/ 10 mg/1 mg per gram (0.05%/1%/0.1% w/w)
|
Cream
|
-
|
S Kant Healthcare Limited
|
India
|
Initial
|
11 January 2023
|
11 January 2028
|
| View |
|
DRP-13235
|
Meropenem (as trihydrate)
|
Surinem-1000
|
1g
|
Powder for injection (IV)
|
-
|
Brooks Laboratories Limited.
|
India
|
Initial
|
06 January 2023
|
06 January 2028
|
| View |
|
DR-XY48565
|
Erlotinib (as hydrochloride)
|
Riltared
|
100 mg
|
Film-Coated Tablet
|
-
|
Dr. Reddy's Laboratories Ltd. (Formulation FTO-7)
|
India
|
Initial
|
11 January 2023
|
11 January 2028
|
| View |
|
DR-XY48561
|
Lidocaine
|
Xylocaine
|
10 mg/0.1 mL per actuation (10% w/v)
|
Topical Spray
|
-
|
Aspen Bad Oldesloe GmbH
|
Germany
|
Initial
|
09 January 2023
|
09 January 2028
|
| View |
|
DRP-13216
|
Meropenem (as trihydrate)
|
Surinem-500
|
500 mg
|
Powder for injection (IV)
|
-
|
Brooks Laboratories Limited
|
India
|
Initial
|
06 January 2023
|
06 January 2028
|
| View |
|
DR-XY48551
|
Carfilzomib
|
Karpilred
|
60 mg
|
Lyophilized Powder for Solution for Injection (IV)
|
-
|
Dr. Reddy's Laboratories Ltd. (Formulation FTO-7)
|
India
|
Monitored Release
|
05 January 2023
|
05 January 2026
|
| View |
|
DRP-13198
|
Cefuroxime (as sodium)
|
Gofuroxime
|
1.5 g
|
Powder for Injection (IM/IV)
|
-
|
Swiss Parenterals Ltd. (Block-B)
|
india
|
Initial
|
06 January 2023
|
06 January 2028
|
| View |
|
DRP-13240
|
Propofol
|
Anepro
|
10 mg / mL
|
Emulsion for IV infusion
|
-
|
Joint Stock Company "Farmak"
|
Ukraine
|
Initial
|
09 January 2023
|
09 January 2028
|
| View |
|
DRP-13219
|
Rocuronium Bromide
|
Romeron
|
10 mg/mL
|
Solution for Injection (IV)
|
-
|
BCWorld Pharm. CO., Ltd.
|
Korea
|
Initial
|
03 January 2023
|
03 January 2028
|
| View |
|
DRP-13234
|
Febuxostat
|
EA Fexustan
|
80 mg
|
Film Coated Tablet
|
-
|
Akriti Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
06 January 2023
|
06 January 2028
|
| View |
|
DRP-13236
|
Omeprazole (as Sodium)
|
Omeyou
|
40 mg
|
Lyophilized Powder for Injection (IV)
|
-
|
Reyoung Pharmaceutical Co. Ltd.
|
China
|
Initial
|
06 January 2023
|
06 January 2028
|
| View |
|
DRP-13233
|
Bupivacaine Hydrochloride
|
Bupisaph
|
5 mg/mL (0.5% w/v) (100 mg/20 mL)
|
Solution for
Injection (Spinal)
|
-
|
Kilitch Drugs (India) Ltd.
|
India
|
Initial
|
06 January 2023
|
06 January 2028
|