| View |
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DR-XY48781
|
Paclitaxel
|
None
|
6mg/mL (30mg/5mL)
|
Concentrate Solution for IV
Infusion
|
Antineoplastic Agent (Taxane)
|
Venus Remedies Limited
|
India
|
Initial
|
23 June 2023
|
23 June 2028
|
| View |
|
DRP-14121
|
Cefepime (as hydrochloride)
|
Myfep
|
1 g
|
Powder for Injection (IM/IV)
|
Antibacterial (Fourth-generation Cephalosporin)
|
Makcur Laboratories Limited
|
India
|
Initial
|
23 June 2023
|
23 June 2028
|
| View |
|
DRP- 14122
|
Rivaroxaban
|
Rixan 20
|
20 mg
|
Film-Coated Tablet
|
Antithrombotic Agent (Direct Factor Xa Inhibitor)
|
Hetero Labs Limited (Unit V)
|
India
|
Initial
|
23 June 2023
|
23 June 2028
|
| View |
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DR-XY48785
|
Gefitinib
|
Gefiset 250
|
250 mg
|
Film-Coated Tablet
|
Antineoplastic (Protein Kinase Inhibitor)
|
Genepharm SA
|
Greece
|
Initial
|
23 June 2023
|
23 June 2028
|
| View |
|
DRP-14123
|
Linezolid
|
Bezlid
|
600 mg
|
Film-Coated Tablet
|
Antibacterial
|
Healer's Lab (Unit II)
|
India
|
Initial
|
23 June 2023
|
23 June 2028
|
| View |
|
DRP-14109
|
Rifampicin + Isoniazid
|
Duasaph-450
|
450 mg/400 mg
|
Film-Coated Tablet
|
Antibacterial/Antituberculosis
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
22 June 2023
|
22 June 2028
|
| View |
|
DRP-14128
|
Gadobutrol
|
Gadovision
|
1 mmol/mL (604.72 mg/mL)
|
Solution for Injection
(I.V.)
|
Paramagnetic contrast media
|
Dongkook Pharmaceutical Co., Ltd.
|
Korea
|
Initial
|
22 December 2023
|
23 June 2028
|
| View |
|
DRP-14114
|
Quetiapine (as fumarate)
|
None
|
200 mg
|
Film-Coated Tablet
|
Antipsychotic
|
Aurobindo Pharma Limited (Unit III)
|
India
|
Initial
|
23 June 2023
|
23 June 2026
|
| View |
|
DRP-14107
|
Betamethasone (as valerate)
|
Adobec
|
0.1% w/w
|
Topical Cream
|
Corticosteroids
|
Rhydburg Pharmaceuticals Ltd.
|
India
|
Initial
|
22 June 2023
|
22 June 2028
|
| View |
|
DRP-14106
|
Betamethasone (as valerate)
|
Fucibet
|
1 mg/g (0.1% w/w)
|
Topical Cream
|
Corticosteroid
|
Rhydburg Pharmaceuticals Ltd.
|
India
|
Initial
|
22 June 2023
|
22 June 2028
|
| View |
|
DRP-14113
|
Quetiapine Fumarate
|
None
|
300 mg
|
Film-Coated Tablets
|
Antipsychotic
|
Aurobindo Pharma Limited (Unit III)
|
India
|
Initial
|
23 June 2023
|
23 June 2028
|
| View |
|
DRP-14116
|
Quetiapine (as fumarate)
|
None
|
25 mg
|
Film-Coated Tablet
|
Antipsychotic
|
Aurobindo Pharma Limited (Unit III)
|
India
|
Initial
|
23 June 2023
|
23 June 2028
|
| View |
|
DR-XY48779
|
Dexmedetomidine (as hydrochloride) in 0.9% Sodium
Chloride
|
|
4 mcg/mL
|
Solution for IV Infusion
|
Hypnotic and Sedative
|
Jiangsu Hengrui Medicine Co., Ltd.
|
China
|
Monitore Release [MR]
|
23 June 2023
|
23 June 2028
|
| View |
|
DRP-14115
|
Quetiapine Fumarate
|
None
|
100 mg
|
Film-Coated Tablet
|
Antipsychotic
|
Aurobindo Pharma Limited (Unit III)
|
India
|
Initial
|
23 June 2023
|
23 June 2028
|
| View |
|
DRP-14118
|
Iron (as Ferrous Sulfate Heptahydrate)
|
None
|
65 mg (equivalent to 325 mg Ferrous Sulfate
Heptahydrate)
|
Film-Coated Tablet
|
Anti-Anemic
|
Phil. United Pharma Corporation.
|
Philippines
|
Initial
|
23 June 2023
|
23 June 2028
|
| View |
|
DRP-14119
|
Iron (as Ferrous Sulfate Heptahydrate) + Folic Acid
|
None
|
60 mg (equivalent to
to 300 mg Ferrous Sulfate Heptahydrate)/ 250 mcg
|
Film-Coated Tablet
|
Anti-Anemic
|
Phil. United Pharma Corporation.
|
Philippines
|
Initial
|
23 June 2023
|
23 June 2028
|
| View |
|
DRP-14117
|
Ascorbic Acid
|
None
|
100 mg/5 mL
|
Syrup
|
Vitamin
|
Phil. United Pharma Corporation.
|
Philippines
|
Initial
|
23 June 2023
|
23 June 2028
|
| View |
|
DRP-14104
|
Clarithromycin
|
Clarisaph-125
|
125mg/5mL
|
Granules For Oral Suspension
|
Antibacterial (Macrolide)
|
Bueno Salud Care (India) Pvt. Ltd.
|
India
|
Initial
|
22 June 2023
|
22 June 2028
|
| View |
|
DRP-14105
|
Clindamycin (as phophate)
|
Klindaver
|
150 mg/mL
|
Solution for IV Infusion
|
-
|
Osel Ilac San ve Tic A.S.
|
Turkey
|
Initial
|
22 June 2023
|
22 June 2028
|
| View |
|
DR-XY48780
|
Multivitamins Minerals
|
None
|
Each film-coated tablet contains:
4 mg
5500 IU
Iron
Vitamin A Acetate
10 mg
Vitamin B1
3.4 mg
Vitamin B2
30 mg
Vitamin B3
Calcium-D Pantothenate (Vitamin Bs)
10 mg
Zinc
3 mg
Vitamin B6
15 mcg
Manganese Calcium
Iodine Magnesium Copper
150 mcg 50 mg
1 mg
15 mg
1 mg
40 mg
Biotin (Vitamin B7)
20 mcg
Folic Acid (Vitamin B9)
0.4 mg
Selenium
9 mcg
Chromium
15 mcg
Vitamin B12
125 mg
Molybdenum
15 mcg
Vitamin C
Vitamin D3
Vitamin E
7.5 mg
400 IU 30 IU
Potassium
Chloride
7.5 mg
|
Film-Coated Tablet
|
-
|
Herbion Pakistan Private Limited
|
Pakistan
|
Initial
|
23 June 2023
|
23 June 2028
|