| View |
|
DR-XY47022
|
Ascorbic Acid
|
None
|
100 mg
|
Tablet
|
-
|
Vonwelt, Inc.
|
Philippines
|
-
|
25 August 2020
|
25 August 2025
|
| View |
|
DR-XY47023
|
Levofloxacin (as Hemihydrate)
|
Wilovex
|
5mg/mL (500mg/ 100mL)
|
Solution for Intravenous Infusion
|
-
|
Hizon Laboratories, Inc.
|
Philippines
|
-
|
20 October 2020
|
20 October 2025
|
| View |
|
DR-XY47024
|
Ambroxol Hydrochloride
|
None
|
30mg/ 5mL
|
Syrup
|
-
|
Fortis Medi Pharmaceutical, Inc.
|
Philippines
|
-
|
28 August 2020
|
28 August 2025
|
| View |
|
DR-XY47025
|
Atomoxetine (As Hydrochloride)
|
ATENCION
|
40mg
|
Capsule
|
-
|
Pharmascience Inc.
|
Canada
|
-
|
28 August 2020
|
28 August 2025
|
| View |
|
DR-XY47026
|
Atomoxetine (As Hydrochloride)
|
ATENCION
|
60mg
|
Capsule
|
-
|
Pharmascience Inc.
|
Canada
|
-
|
28 August 2020
|
28 August 2025
|
| View |
|
DR-XY47027
|
Cetrorelix (as acetate)
|
Cetrolix
|
250 mcg
|
Lyophilized Powder For Injection (SC)
|
-
|
Gufic Biosciences Limited.
|
India
|
Initial
|
28 August 2020
|
28 August 2025
|
| View |
|
DR-XY47028
|
Tacrolimus
|
Protopic
|
1 mg/g (0.1%)
|
Ointment
|
-
|
Leo Laboratories Ltd
|
Ireland
|
-
|
16 November 2021
|
16 November 2026
|
| View |
|
DR-XY47029
|
Tacrolimus
|
Protopic
|
300 mcg/g (0.03%)
|
Topical Ointment
|
-
|
Leo Laboratories Ltd
|
Ireland
|
-
|
16 November 2021
|
16 November 2026
|
| View |
|
DR-XY47030
|
Cefuroxime (as sodium)
|
Teroxime
|
1.5 g
|
Powder For Injection
|
Antibacterial (Cephalosporin)
|
Sance Laboratories Pvt.Ltd.
|
India
|
Monitored Release
|
11 January 2022
|
11 January 2027
|
| View |
|
DR-XY47032
|
Atomoxetine (As Hydrochloride)
|
ATENCION
|
10mg
|
Capsule
|
-
|
Pharmascience Inc.
|
Canada
|
-
|
28 August 2020
|
28 August 2025
|
| View |
|
DR-XY47033
|
Atomoxetine (As Hydrochloride)
|
ATENCION
|
18mg
|
Capsule
|
-
|
Pharmascience Inc.
|
Canada
|
-
|
28 August 2020
|
28 August 2025
|
| View |
|
DR-XY47034
|
Quetiapine (As Fumarate)
|
Qtipine 100
|
100 mg
|
Film-Coated Tablet
|
-
|
TORRENT PHARMACEUTICALS LTD.
|
India
|
-
|
06 October 2020
|
06 October 2025
|
| View |
|
DR-XY47035
|
Amino Acids
|
Prosumin Nephro
|
0.054
|
Solution For I.V Infusion
|
-
|
JW Life Science Corporation
|
Korea
|
-
|
09 September 2020
|
09 September 2025
|
| View |
DR-XY47036_PI_01.pdf
|
DR-XY47036
|
Parecoxib (As Sodium)
|
Parebrex
|
40 mg
|
Lyophilized Powder for Injection (I.V./I.M.)
|
Selective COX-2 Inhibitor
|
Mylan Laboratories Limited (Hosur Sterile Facility) -
|
India
|
Initial (Reconstruction)
|
31 July 2024
|
04 September 2025
|
| View |
|
DR-XY47037
|
ROSUVASTATIN (as calcium)
|
Rosukon-20
|
20 mg
|
Tablet
|
-
|
Magbro Healthcare Pvt Ltd
|
India
|
Initial
|
06 October 2020
|
06 October 2025
|
| View |
|
DR-XY47038
|
Memantine Hydrochloride
|
Alzhemed 10
|
10 mg
|
Film Coated Tablet
|
-
|
Unison Laboratories Co., Ltd
|
Thailand
|
Initial
|
06 October 2020
|
06 October 2025
|
| View |
|
DR-XY47039
|
Amlodipine ( as Besylate ) + Valsartan
|
Valsaram
|
10 mg/ 160 mg
|
Film-Coated Tablet
|
-
|
GENUONE Sciences Inc.
|
Korea
|
Initial (Reconstruction)
|
18 August 2022
|
09 September 2025
|
| View |
|
DR-XY47040
|
Amlodipine (as Besilate) + Valsartan
|
Valsaram
|
5 mg / 160 mg
|
Film-Coated Tablet
|
-
|
GENUONE Sciences Inc.
|
Korea
|
Initial (Reconstruction)
|
18 August 2022
|
09 September 2025
|
| View |
|
DR-XY47041
|
Amlodipine (as Besilate) + Valsartan
|
Valsaram
|
5 mg / 80 mg
|
Film-Coated Tablet
|
-
|
GENUONE Sciences Inc.
|
Korea
|
Initial (Reconstruction)
|
18 August 2022
|
09 September 2025
|
| View |
|
DR-XY47042
|
Ascorbic Acid + Zinc
|
Cixtor-Z
|
100 mg/10 mg (Equivalent to 27.45mg Zinc Sulfate Monohydrate ) per 5mL Syrup
|
Syrup
|
-
|
LLOYD LABORATORIES, INC.
|
Philippines
|
-
|
04 September 2020
|
04 September 2025
|