| View |
|
DR-XY47653
|
Atomoxetine (as hydrochloride)
|
Attentrol 40
|
40 mg
|
Capsule
|
Psychostimulant (Centrally Acting Sympathomimetic)
|
Sun Pharmaceutical Industries Limited
|
India
|
Initial
|
07 January 2022
|
07 January 2027
|
| View |
|
DR-XY47654
|
Atomoxetine (as hydrochloride)
|
Attentrol 18
|
18 mg
|
Capsule
|
Psychostimulant (Centrally Acting Sympathomimetic)
|
Sun Pharmaceutical Industries Limited
|
India
|
Initial
|
07 January 2022
|
07 January 2027
|
| View |
|
DR-XY47655
|
Atomoxetine (as hydrochloride)
|
Attentrol 25
|
25 mg
|
Capsule
|
Psychostimulant (Centrally Acting Sympathomimetic)
|
Sun Pharmaceutical Industries Limited
|
India
|
Initial
|
07 January 2022
|
07 January 2027
|
| View |
|
DR-XY47656
|
Oxaliplatin
|
Platinox
|
100 mg
|
Lyophilized Powder For Injection (I.V. Infusion)
|
-
|
Korea United Pharm. Inc.
|
Korea
|
-
|
07 January 2022
|
07 January 2027
|
| View |
|
DR-XY47657
|
Gefitinib
|
Veiasu
|
250 mg
|
Film-Coated Tablet
|
Antineoplastic
|
Lotus Pharmaceutical Co., Ltd. (Nantou Plant)
|
Taiwan
|
Initial
|
10 January 2022
|
10 January 2027
|
| View |
|
DR-XY47658
|
Ticagrelor
|
Agraplat
|
90 mg
|
Film-Coated Tablet
|
-
|
Ajanta Pharma Limited
|
India
|
-
|
10 January 2022
|
10 January 2027
|
| View |
|
DR-XY47659
|
Lenalidomide
|
Lenagen
|
25 mg
|
Capsule
|
Immunosuppressant
|
Lotus Pharmaceutical Co., Ltd. (Nantou Plant)
|
Taiwan
|
Monitored Release
|
11 January 2022
|
11 January 2027
|
| View |
|
DR-XY47660
|
Lenalidomide
|
Lenagen
|
15 mg
|
Capsule
|
Immunosuppressant
|
Lotus Pharmaceutical Co., Ltd. (Nantou Plant)
|
Taiwan
|
Monitored Release
|
11 January 2022
|
11 January 2027
|
| View |
|
DR-XY47661
|
Lenalidomide
|
Lenagen
|
10 mg
|
Capsule
|
Immunosuppressant
|
Lotus Pharmaceutical Co., Ltd. (Nantou Plant)
|
Taiwan
|
Monitored Release
|
11 January 2022
|
11 January 2027
|
| View |
|
DR-XY47662
|
Lenalidomide
|
Lenagen
|
5 mg
|
Capsule
|
Immunosuppressant
|
Lotus Pharmaceutical Co., Ltd. (Nantou Plant)
|
Taiwan
|
Monitored Release
|
11 January 2022
|
11 January 2027
|
| View |
|
DR-XY47663
|
Aripiprazole
|
Arpivex 15
|
15 mg
|
Orally Disintegrating Tablet
|
Antipsychotic
|
West Coast Pharmaceutical Works Ltd.
|
India
|
Initial
|
13 January 2022
|
13 January 2027
|
| View |
|
DR-XY47664
|
Dexmedetomidine (as Hydrochloride)
|
Kabimidine
|
100 mcg/mL (200 mcg/ 2 mL)
|
Sterile Solution for I.V. Injection
|
Hypnotic/ Sedative
|
Gland Pharma Limited
|
India
|
Initial (Reconstruction)
|
31 July 2024
|
11 January 2027
|
| View |
|
DR-XY47665
|
Ascorbic Acid + Zinc
|
Immunostan
|
500 mg (equivalent to 562.43 mg Sodium Ascorbate)/10 mg (equivalent to 70 mg Zinc
Gluconate)
|
Capsule
|
Vitamin / Mineral
|
J.M. Tolmann Laboratories Inc.
|
Philippines
|
Initial
|
12 January 2022
|
12 January 2027
|
| View |
|
DR-XY47666
|
Medroxyprogesterone acetate
|
Medroxin
|
150mg/mL
|
Suspension for Injection (IM)
|
-
|
PT Harsen Laboratories
|
Indonesia
|
-
|
14 January 2022
|
14 January 2027
|
| View |
|
DR-XY47667
|
Diclofenac Sodium
|
Voren
|
50 mg
|
Rectal Suppository
|
-
|
Y.S.P. Industries (M) Sdn. Bhd.
|
Malaysia
|
-
|
18 January 2022
|
18 January 2027
|
| View |
|
DR-XY47668
|
Diclofenac Sodium
|
Voren
|
12.5 mg
|
Rectal Suppository
|
Non-Steroidal Anti-Inflammatory (Acetic Acid Derivative)
|
Y.S.P. Industries (M) Sdn. Bhd.
|
Malaysia
|
Initial
|
18 January 2022
|
18 January 2027
|
| View |
|
DR-XY47669
|
Diclofenac Sodium
|
Voren
|
25 mg
|
Rectal Suppository
|
-
|
Y.S.P. Industries (M) Sdn. Bhd.
|
Malaysia
|
-
|
18 January 2022
|
18 January 2027
|
| View |
|
DR-XY47670
|
Metronidazole
|
Sydenzole
|
500 mg
|
Tablet
|
Antiprotozoal
|
Sydenham Laboratories, Inc.
|
Philippines
|
Initial
|
19 January 2022
|
19 January 2027
|
| View |
DR-XY47671_PI_01.pdf
|
DR-XY47671
|
Metronidazole
|
Flagimax
|
500 mg
|
Tablet
|
Antiprotozoal
|
Sydenham Laboratories, Inc.
|
Philippines
|
Initial (Correction)
|
19 January 2023
|
19 January 2027
|
| View |
|
DR-XY47672
|
Gliclazide
|
Diakon
|
80 mg
|
Tablet
|
Blood Glucose Lowering Drug (Sulfonylurea)
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial
|
25 January 2022
|
25 January 2027
|