| View |
|
DR-XY48568
|
Dasatinib
|
Dasamia 80
|
80 mg
|
Film-Coated Tablet
|
Antineoplastic Agent (BCR-ABL Tyrosine Kinase
Inhibitor)
|
Sun Pharma Laboratories Ltd.
|
India
|
Monitored (Correction)
|
05 June 2024
|
18 January 2028
|
| View |
|
DR-XY48569
|
Ascorbic Acid
|
Doctri-Cee
|
533.40 mg (equivalent to 600 mg as Sodium Ascorbate)
|
Capsule
|
-
|
Theramedic Laboratories Corp.
|
Philippines
|
Initial (OTC)
|
11 January 2023
|
11 January 2028
|
| View |
|
DR-XY48570
|
Alpha Ketoanalogues + Essential Amino Acids
|
None
|
Each sachet contains:
Calcium-3-methyl-2-oxovalerate (a- Ketoanalogue of isoleucine, Calcium salt) -201 mg Calcium-4-methyl-2-oxovalerate (a- Ketoanalogue of leucine, Calcium salt) - 303 mg
Calcium-2-oxo-3-phenylpropionate (a-Ketoanalogue of phenylalanine, Calcium salt) - 204 mg Calcium-3-methyl.2-oxobutyrate (a- Ketoanalogue of valine, Calcium salt) - 258 mg
Calcium-DL-2-hydroxy-4-( methylthio )-butyrate (a-Hydroxy analogue of methionine, Calcium-salt) -177 mg
L-Lysine Acetate - 315 mg
L-Threonine - 159 mg
L-Tryptophan - 69 mg
L-Histidine-114 mg
L-Tyrosine 90 mg
Total Nitrogen content I sachet 108mg
Calcium/sachet 3.75 mmol = 150 mg
|
Granules For Oral Solution
|
-
|
Pharose Remedies Limited
|
India
|
Monitored Release
|
17 January 2023
|
17 January 2028
|
| View |
|
DR-XY48571
|
Alpha Ketoanalogues + Essential Amino Acids
|
None
|
Each sachet contains:
Calcium-3-methyl-2-oxovalerate (a- Ketoanalogue of isoleucine, Calcium salt) - 201 mg Calcium-4-methyl-2-oxovalerate (a- Ketoanalogue of leucine, Calcium salt) - 303 mg
Calcium-2-oxo-3-phenylpropionate (a-Ketoanalogue of phenylalanine, Calcium salt) - 204 mg
Calcium-3-methyl.2-oxobutyrate (a- Ketoanalogue of valine, Calcium salt) - 258 mg
Calcium-DL-2-hydroxy-4-( methylthio )-butyrate (a-Hydroxy analogue of methionine, Calcium-salt) -
177 mg
L-Lysine Acetate - 315 mg
L-Threonine 159 mg
-
L-Tryptophan - 69 mg
L-Histidine-114 mg
L-Tyrosine 90 mg
Total Nitrogen content I sachet 108mg
Calcium/sachet 3.75 mmol = 150 mg
|
Granules For Oral Solution
|
-
|
Pharose Remedies Limited
|
India
|
Monitored Release
|
24 January 2023
|
24 January 2028
|
| View |
|
DR-XY48572
|
Moxifloxacin (as hydrochloride)
|
Auromox
|
5 mg/mL (0.5% w/v)
|
Ophthalmic Solution (Eye Drop)
|
-
|
Aurolab
|
India
|
Initial
|
18 January 2023
|
18 January 2028
|
| View |
|
DR-XY48573
|
Mometasone Furoate
|
Melomet
|
1 mg/g (0.1% w/w)
|
Topical Cream
|
-
|
Y.S.P. Industries (M) SDN. BHD.
|
Malaysia
|
Initial (OTC)
|
26 January 2023
|
26 January 2028
|
| View |
|
DR-XY48576
|
Ticagrelor
|
None
|
90 mg
|
Film-Coated Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
23 January 2023
|
23 January 2028
|
| View |
|
DR-XY48577
|
Bortezomib
|
Tezomin
|
3.5 mg
|
Lyophilized Powder For Injection (IV,SC)
|
-
|
Korea United Pharm Inc..
|
Korea
|
Initial
|
23 January 2023
|
23 January 2028
|
| View |
|
DR-XY48578
|
Colecalciferol (Vitamin D3)
|
Pure-Dee
|
5000 IU
|
Capsule
|
-
|
Growrich Manufacturing Inc.
|
Philippines
|
Initial (OTC)
|
26 January 2023
|
26 January 2028
|
| View |
|
DR-XY48579
|
Colecalciferol (Vitamin D3)
|
Dbrite
|
5000 IU
|
Capsule
|
-
|
Growrich Manufacturing Inc.
|
Philippines
|
Initial (OTC)
|
26 January 2023
|
26 January 2028
|
| View |
|
DR-XY4858
|
Pheniramine Maleate/ Naphazoline Hydrochloride
|
Naphcon-A
|
3 mg/ 250 mcg/mL
|
Ophthalmic Solution
|
Antihistamines/ Decongestants
|
Alcon Singapore Manufacturing Pte. Ltd.
|
Singapore
|
Automatic Renewal
|
06 July 2022
|
01 September 2027
|
| View |
|
DR-XY48580
|
Hydroquinone
|
Melashine
|
40 mg/g (4% w/w)
|
Cream
|
-
|
Y.S.P. Industries (M) Sdn. Bhd.
|
Malaysia
|
Initial (OTC)
|
02 February 2023
|
02 February 2028
|
| View |
|
DR-XY48581
|
Hydroquinone
|
Melaquin
|
40 mg/g (4% w/w)
|
Cream
|
-
|
Y.S.P. Industries (M) Sdn. Bhd.
|
Malaysia
|
Initial (OTC)
|
02 February 2023
|
02 February 2028
|
| View |
|
DR-XY48582
|
Potassium Citrate
|
None
|
1080 mg (10 mEq)
|
Extended Release Tablet
|
-
|
Eskayef Pharmaceuticals Limited
|
Bangladesh
|
Initial
|
25 January 2023
|
25 January 2028
|
| View |
|
DR-XY48583
|
Hyoscine Butylbromide
|
Khrizcopan
|
10 mg
|
Tablet
|
-
|
Merit Organics Ltd.
|
India
|
Initial
|
26 January 2023
|
26 January 2028
|
| View |
|
DR-XY48584
|
Diphenhydramine hydrochloride.
|
Diphenpors
|
50 mg/mL
|
Solution for Injection (IM/IV)
|
-
|
Kwality Pharmaceuticals Ltd.
|
India
|
Initial
|
27 January 2023
|
27 January 2028
|
| View |
DR-XY48585_PI_01.pdf
|
DR-XY48585
|
Lurasidone Hydrochloride
|
Latuda
|
40 mg
|
Film Coated Tablet
|
-
|
Bushu Pharmaceuticals Ltd. (Kawagoe Factory)
|
Japan
|
Monitored Release
|
08 February 2023
|
08 February 2028
|
| View |
DR-XY48586_PI_01.pdf
|
DR-XY48586
|
Lurasidone Hydrochloride
|
Latuda
|
80 mg
|
Film-Coated Tablet
|
-
|
Bushu Pharmaceuticals Ltd. (Kawagoe Factory)
|
Japan
|
Monitored Release
|
08 February 2023
|
08 February 2028
|
| View |
|
DR-XY48587
|
Sitagliptin (as phosphate monohydrate)
|
Torsit 25
|
25 mg
|
Film-Coated Tablet
|
-
|
Torrent Pharmaceuticals Ltd.
|
India
|
Initial
|
30 January 2023
|
30 January 2028
|
| View |
|
DR-XY48588
|
Sitagliptin (as phosphate monohydrate)
|
Torsit 50
|
50 mg
|
Film-Coated Tablet
|
-
|
Torrent Pharmaceuticals Ltd.
|
India
|
Initial
|
30 January 2023
|
30 January 2028
|