| View |
|
DR-XY46832
|
Voriconazole
|
Vorigen
|
200 mg
|
Lyophilized Powder for I.V. Infusion
|
-
|
Gen İlaç ve Sağlık Ürünleri San Ve Tic. A.Ş.
|
Turkey
|
Initial (Variation)
|
16 November 2023
|
16 November 2028
|
| View |
|
DRP-14181
|
Paracetamol
|
None
|
500 mg
|
Tablet
|
-
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial
|
14 July 2023
|
14 July 2028
|
| View |
|
DRP-14626
|
Gemcitabine (as hydrochloride)
|
Spagem
|
200 mg
|
Lyophilized Powder for Injection for I.V.
Infusion
|
-
|
SP Accure Labs Pvt. Ltd.
|
India
|
Initial
|
07 November 2023
|
07 November 2028
|
| View |
|
DRP-14200
|
Esomeprazole (As Magnesium Trihydrate)
|
Prexia
|
40mg
|
Enteric Coated Tablet
|
-
|
Lincoln Pharmaceutical Ltd.
|
India
|
Initial
|
18 July 2023
|
18 July 2028
|
| View |
|
DRP-14163
|
Rivaroxaban
|
Rixan 15
|
15 mg
|
Film-Coated Tablet
|
-
|
Hetero Labs Limited (Unit V)
|
India
|
Initial
|
07 July 2023
|
07 July 2028
|
| View |
|
DRP-14625
|
Gemcitabine (as hydrochloride)
|
Spagem
|
1 g
|
Lyophilized Powder for Injection for I.V. Infusion
|
-
|
SP Accure Labs Pvt. Ltd.
|
India
|
Initial
|
07 November 2023
|
07 November 2028
|
| View |
|
DRP-14197
|
Furosemide
|
Diurmed
|
40mg
|
Film-Coated Tablet
|
-
|
MAGBRO HEALTHCARE PVT. LTD.
|
India
|
Initial
|
18 July 2023
|
18 July 2028
|
| View |
|
DRHR-2317
|
Isopropyl Alcohol
|
BD Alcohol Swab
|
70% (v/v)
|
Swab
|
-
|
BD Medical Diabetes Care
|
U.S.A.
|
Initial
|
20 December 2023
|
20 December 2028
|
| View |
|
DRP-14162
|
Polymyxin B (as sulfate)
|
Polyject-B
|
500,000 Units
|
Powder for Solution for Injection
(Intrathecal/IM/IV)
|
-
|
SWISS PARENTERALS LTD.
|
India
|
Initial
|
06 July 2023
|
06 July 2028
|
| View |
|
DR-XY48927
|
Paracetamol + Ibuprofen
|
AlaxanR Xtra (for BNC)
|
325 mg / 200 mg (equivalent to 256.23 mg Ibuprofen as
Sodium dihydrate)
|
Tablet
|
-
|
UNILAB, Inc.
|
Philippines
|
Initial
|
22 November 2023
|
22 November 2028
|
| View |
|
DR-XY48937
|
Multivitamins + Minerals
|
Berocca Energy
|
Each Effervescent Tablet contains:
Ascorbic Acid (Vitamin C)
500mg
Riboflavin (Vitamin B.)
15mg
Calcium (as calcium carbonate and calcium pantothenate)
100mg
Pyridoxine hydrochloride (Vitamin B)
10mg
Magnesium (as magnesium carbonate and magnesium sulfate dihydrate) 100mg
Zinc (as zinc citrate trihydrate)
10mg
400mcg
Nicotinamide (Vitamin B1)
50mg
Folic acid
150mcg
Pantothenic acid (Vitamin B1)
23mg
Biotin (Vitamin H)
Thiamine hydrochloride (Vitamin B1)
15mg
Cyanocobalamin (Vitamin B12)
10mcg
3 mm
84 mm
4.5 mm
11 mm
|
Effervescent Tablet
|
Vitamins / Minerals
|
PT. Bayer Indonesia
|
Indonesia
|
Initial (Correction)
|
02 April 2024
|
29 November 2028
|
| View |
|
DR-XY48939
|
Multivitamins + Minerals
|
Berocca Energy
|
Each Effervescent Tablet contains:
Ascorbic Acid (Vitamin C)
500mg
Riboflavin (Vitamin B2)
15mg
Calcium (as calcium carbonate and calcium pantothenate)
100mg
Pyridoxine hydrochloride (Vitamin B1)
10mg
Magnesium (as magnesium carbonate and magnesium sulfate dihydrate) 100mg
Zinc (as zinc citrate trihydrate)
10mg
400mcg
Nicotinamide (Vitamin B1)
50mg
Folic acid
Pantothenic acid (Vitamin Bs)
23mg
Biotin (Vitamin H)
150mcg
Thiamine hydrochloride (Vitamin B1)
15mg
Cyanocobalamin (Vitamin B12)
10mcg
|
Effervescent Tablet (Mango Flavor)
|
Vitamins Minerals
|
PT. Bayer Indonesia
|
Indonesia
|
Initial (Correction)
|
02 April 2024
|
29 November 2028
|
| View |
|
DR-XY48938
|
Multivitamins + Minerals
|
Berocca Energy
|
Each Effervescent Tablet contains:
15mg
500mg
Riboflavin (Vitamin B2)
Ascorbic Acid (Vitamin C)
Calcium (as calcium carbonate and calcium pantothenate)
100mg
Pyridoxine hydrochloride (Vitamin B)
10mg
10my
Magnesium (as magnesium carbonate and magnesium sulfate dihydrate) 100mg
Zinc (as zinc citrate trihydrate)
50mg
Nicotinamide (Vitamin B1)
23mg
Pantothenic acid (Vitamin B5)
Thiamine hydrochloride (Vitamin B1)
15mg
Folic acid
Biotin (Vitamin H)
Cyanocobalamin (Vitamin B1:)
400mcg
150mcg
10mcg
3 mm
119 mm
4.5 mm
|
Effervescent Tablet
|
-
|
PT. Bayer Indonesia
|
Indonesia
|
Initial
|
29 November 2023
|
29 November 2028
|
| View |
|
DRP-14680
|
Thiamine hydrochloride (Vitamin B6) + Cyanocobalamin (Vitamin B12) + Iron + Folic acid
|
Rategen
|
Each Film-Coated Tablet contains:
Pyridoxine hydrochloride (Vitamin B6)
Cyanocobalamin (Vitamin B12)
Iron (equivalent to187.5 mg Ferrous sulfate)
Folic acid
20 mg
25 mcg
60 mg
600 mcg
|
Film-Coated Tablet
|
-
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
Initial
|
28 November 2023
|
28 November 2028
|
| View |
|
DRP-14199
|
Etoricoxib
|
None
|
120 mg
|
Film-Coated Tablet
|
-
|
USV Private Limited
|
India
|
Initial
|
18 July 2023
|
18 July 2028
|
| View |
|
DRP-14721
|
Cefotaxime (as sodium)
|
Zefcefox
|
500 mg
|
Powder for Injection (IM/IV)
|
-
|
Innova Captab Limited
|
India
|
Initial
|
04 December 2023
|
04 December 2028
|
| View |
|
DRP-14720
|
Cefotaxime (as sodium)
|
Zefcefox
|
1 g
|
Powder for Injection (IM/IV)
|
-
|
Innova Captab Limited
|
India
|
Initial
|
04 December 2023
|
04 December 2028
|
| View |
|
DRP-14556
|
Fulvestrant
|
Fulvetop
|
50 mg/mL (250 mg/5 mL)
|
Solution for Injection (IM)
|
-
|
Jiangsu Hansoh Pharmaceutical Co. Ltd.
|
China
|
Initial
|
13 October 2023
|
13 October 2028
|
| View |
|
DRP-14692
|
Diosmin Hesperidin
|
Venotion
|
900 mg / 100 mg
|
Film-Coated Tablet
|
Vasoprotective
|
Mepro Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
28 November 2023
|
28 November 2025
|
| View |
|
DRP-14238
|
Co-Amoxiclav
|
Clavixo
|
Formulation:
Each vial contains:
Amoxicillin (as sodium) lg
Clavulanic acid
200 mg
|
Powder for Injection (IV)
|
Antibacterial (Penicillin/Beta-lactamase Inhibitor)
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial [Correction]
|
17 May 2024
|
02 August 2028
|