| View |
|
DR-XY47734
|
Biotin (Vitamin B7)
|
None
|
5,000 mcg
|
Capsule
|
Vitamin
|
Factors Group of Nutritional Companies Inc.
|
Canada
|
Initial
|
16 February 2022
|
16 February 2027
|
| View |
|
DR-XY47735
|
Omidenepag Isopropyl
|
Eybelis
|
20 mcg/mL (0.002% w/v)
|
Sterile Ophthalmic Solution
|
-
|
Santen Pharmaceutical Co., Ltd. (Shiga Plant)
|
Japan
|
-
|
22 February 2022
|
22 February 2025
|
| View |
|
DR-XY47736
|
Zoledronic acid (as monohydrate)
|
Myzole
|
4 mg/5 mL
|
Concentrate Solution for IV Infusion
|
Biphosphanates
|
Mylan Laboratories Limited (Specialty Formulation
Facility)
|
India
|
Initial
|
22 February 2022
|
22 February 2027
|
| View |
|
DR-XY47737
|
Acetylcysteine
|
Fluiject
|
200 mg
|
Powder For Oral Solution
|
Mucolytic
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
16 February 2022
|
16 February 2027
|
| View |
|
DR-XY47738
|
Vinorelbine (as tartrate)
|
Vinobin
|
30 mg
|
Softgel capsule
|
Antineoplastic (Vinca alkaloid and analogue)
|
Lotus Pharmaceutical Co., Ltd. (Nantou Plant)
|
Taiwan
|
Monitored Release
|
10 March 2022
|
10 March 2027
|
| View |
|
DR-XY47739
|
Doripenem (as monohydrate)
|
Dopinem
|
500mg
|
Powder for Infusion (IV)
|
Antibacterial (Carbapenem)
|
PT. Dexa Medica
|
Indonesia
|
Initial
|
18 February 2022
|
18 February 2027
|
| View |
|
DR-XY47740
|
Zinc (as citrate dihydrate)
|
None
|
50 mg (equivalent to 159.8 mg Zinc Citrate Dihydrate)
|
Tablet
|
Mineral
|
Factors Group of Nutritional Companies Inc.
|
Canada
|
Initial
|
18 February 2022
|
18 February 2027
|
| View |
|
DR-XY47741
|
Voriconazole
|
Trilam
|
200 mg
|
Powder For Injection (I.V.)
|
Antifungal
|
Mylan Laboratories Limited (Hosur Sterile Facility)
|
India
|
Initial
|
22 February 2022
|
22 February 2027
|
| View |
DR-XY47742_PI_01.pdf
|
DR-XY47742
|
Abemaciclib
|
Yulareb
|
50 mg
|
Film-Coated Tablet
|
-
|
Lilly del Caribe, Inc.
|
U.S.A
|
Monitored Release
|
22 February 2022
|
22 February 2027
|
| View |
DR-XY47743_PI_01.pdf
|
DR-XY47743
|
Abemaciclib
|
Yulareb
|
100 mg
|
Film-Coated Tablet
|
-
|
Lilly del Caribe, Inc.
|
U.S.A
|
Monitored Release
|
22 February 2022
|
22 February 2027
|
| View |
DR-XY47744_PI_01.pdf
|
DR-XY47744
|
Abemaciclib
|
Yulareb
|
150 mg
|
Film-Coated Tablet
|
Antineoplastic Agent [Protein Kinase Inhibitor (Cyclin Dependent Kinase (CDK) Inhibitor)]
|
Lilly del Caribe, Inc.
|
United States of America
|
Monitored Release (Variation
|
21 September 2022
|
21 September 2027
|
| View |
DR-XY47745_PI_01.pdf
|
DR-XY47745
|
Abemaciclib
|
Yulareb
|
200 mg
|
Film-Coated Tablet
|
Antineoplastic Agent [Protein Kinase Inhibitor (Cyclin Dependent Kinase (CDK) Inhibitor)]
|
Lilly del Caribe, Inc.
|
United States of America
|
Monitored Release (Variation
|
21 September 2022
|
21 September 2027
|
| View |
|
DR-XY47746
|
Naltrexone Hydrochloride
|
Nodict
|
50 mg
|
Film-Coated Tablet
|
Opioid Antagonist
|
Sun Pharmaceutical Industries Ltd.
|
India
|
Monitored Release (Reconstruction)
|
27 June 2024
|
22 February 2027
|
| View |
|
DR-XY47747
|
Entecavir (as monohydrate)
|
Hepwin 0.5
|
500 mcg
|
Film-Coated Tablet
|
Antiviral
|
Mylan Laboratories Limited
|
India
|
Initial
|
28 February 2022
|
28 February 2027
|
| View |
|
DR-XY47748
|
Entecavir (as monohydrate)
|
Hepwin 1
|
1 mg
|
Film-Coated Tablet
|
Antiviral
|
Mylan Laboratories Limited
|
India
|
Initial
|
28 February 2022
|
28 February 2027
|
| View |
|
DR-XY47749
|
Epirubicin Hydrochloride
|
Epribenz-50
|
50mg
|
Lyophilized Powder for Injection (IV/Intravesical)
|
Antineoplastic Agent
|
ADMAC Lifesciences
|
India
|
Initial
|
23 February 2022
|
23 February 2027
|
| View |
|
DR-XY47750
|
Epirubicin Hydrochloride
|
Epribenz-10
|
10mg
|
Lyophilized Powder for Injection (IV/Intravesical)
|
Antineoplastic Agent
|
ADMAC Lifesciences
|
India
|
Initial
|
23 February 2022
|
23 February 2027
|
| View |
|
DR-XY47751
|
Estradiol valerate
|
Progynova
|
2 mg
|
Sugar-Coated Tablet
|
Estrogen
|
Bayer Weimar Gmbh Und Co. Kg
|
Germany
|
Initial
|
28 February 2022
|
28 February 2027
|
| View |
|
DR-XY47752
|
Ascorbic Acid
|
Marphen C
|
600mg (equivalent to 553.40mg Ascorbic Acid and 46.60mg Sodium Ascorbate)
|
Capsule
|
Vitamin
|
Herbz Med Pharma Corporation
|
Philippines
|
Initial
|
28 February 2022
|
28 February 2027
|
| View |
|
DR-XY47753
|
Emergency Kit
|
Mediplast
|
One pouch contains:
3x3 Mediplast Gauze Pads-2 pieces 120 mL Rhea 10% Hydrogen peroxide-1 bottle Mediplast Bantam Plastic Strips-12 pieces
15 mL Rhea Povidone Iodine-1 bottle 1.25cmx9m Meditape Paper Tape-1 roll 10 g Cleene Absorbent Cotton-1 roll 2x6 Mediplast Gauze Bandages-2 pieces 60 mL Rhea 70% Isopropyl Alcohol-1 bottle Mediplast Face Mask-1 piece Flashlight with Whistle-1 piece Aquatabs Troclosene Sodium 67 mg effervescent tablet-2 tablets
|
N/A
|
-
|
Philusa Corporation
|
Philippines
|
-
|
28 February 2022
|
28 February 2027
|