| View |
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DR-XY48982
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Eicosapentaenoic acid (EPA) Ethyl Docosahexaenoic acid (DHA) Ethyl Ester
|
Romega
|
465 mg/375 mg
|
Softgel Capsule
|
-
|
Humanwell Puracap Pharmaceuticals (Wuhan) Co.,
Ltd.
|
China
|
Monitored Release (MR)
|
19 January 2024
|
19 January 2029
|
| View |
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DR-XY48983
|
Retinol Palmitate (Vitamin A) + Ascorbic (Vitamin C) + dl-a-Tocopheryl acetate (Vitamin E) + Pyridoxine (Vitamin B6) + Zinc
|
Vitamace
|
3000 IU/500 mg/100 IU/1.95 mg (equivalent to 2.37 mg Pyridoxine hydrochloride)/25 mg (equivalent to 31.12 mg of Zinc Oxide)
|
Softgel Capsule
|
-
|
Phil Inter Pharma Co. Ltd.
|
Vietnam
|
Initial
|
23 January 2024
|
23 January 2029
|
| View |
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DR-XY48984
|
Remdesivir
|
Desrem
|
100 mg
|
Lyophilized Powder for Solution for I.V. Infusion
|
-
|
Gland Pharma Limited
|
India
|
Monitored Release
|
24 January 2024
|
24 January 2029
|
| View |
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DR-XY48985
|
Oxaliplatin
|
Doxatin
|
50 mg
|
Lyophilized Powder for Injection (IV Infusion)
|
-
|
Cisen Pharmaceutical Co., Ltd.
|
China
|
Initial
|
25 January 2024
|
25 January 2029
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| View |
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DR-XY48986
|
Rasagiline (as mesilate)
|
Rasator 1
|
1 mg
|
Tablet
|
-
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TORRENT PHARMACEUTICALS LTD.
|
India
|
Initial
|
25 January 2024
|
25 January 2029
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| View |
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DR-XY48987
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0.9% Sodium Chloride
|
Visoline
|
9 mg/mL (0.9% w/v)
|
Solution for IV Infusion
|
-
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Vision Pharmaceuticals
|
Pakistan
|
Initial
|
25 January 2024
|
25 January 2029
|
| View |
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DR-XY48989
|
Hydroquinone + Tretinoin
|
None
|
27 mg/100 mcg per mL
|
Topical Solution
|
-
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Altum International Cosmeceutical Manufacturing
|
Philippines
|
Initial [OTC]
|
25 January 2024
|
25 January 2029
|
| View |
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DR-XY48990
|
Hydroquinone + Tretinoin
|
None
|
30mg/300mcg per gram
|
Topical Cream
|
-
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Altum International Cosmeceutical Manufacturing
|
Philippines
|
Initial [OTC]
|
25 January 2024
|
25 January 2029
|
| View |
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DR-XY48991
|
Pantoprazole (as sodium sesquihydrate)
|
Porsprazole
|
40mg
|
Lyophilized Powder for Injection (I.V.)
|
-
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Med Biopharm Pvt. Ltd.
|
India
|
Initial
|
26 January 2024
|
26 January 2029
|
| View |
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DR-XY48992
|
Nepafenac
|
Neypac
|
1 mg/mL (0.1% w/v)
|
Sterile Ophthalmic Suspension (Eye Drops)
|
-
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Axa Parenterals Limited
|
India
|
Initial
|
26 January 2024
|
26 January 2029
|
| View |
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DR-XY48993
|
Oseltamivir (as phosphate)
|
None
|
75 mg
|
Capsule
|
-
|
Korea United Pharm. Inc.
|
Korea
|
Initial
|
26 January 2024
|
26 January 2029
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| View |
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DR-XY48994
|
Moxifloxacin (as hydrochloride)
|
None
|
400mg
|
Film-Coated Tablet
|
Antibacterial (Fluoroquinolone)
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Lupin Limited
|
India
|
Initial
|
31 January 2024
|
31 January 2029
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| View |
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DR-XY48995
|
Aluminum hydroxide + Magnesium hydroxide +
Simethicone
|
Contylan Advance
|
225 mg/200 mg/30 mg
|
Tablet
|
Antacid/Antiflatulent
|
Lejal Laboratories, Inc.
|
Philippines
|
Initial
|
31 January 2024
|
31 January 2029
|
| View |
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DR-XY48996
|
Fulvestrant
|
Fulveskal
|
50 mg/mL (250 mg/5 mL)
|
Solution for Injection (IM)
|
Anti-estrogen (Endocrine Therapy)
|
Chia Tai-Tianqing Pharmaceutical Group Co., Ltd.
|
China
|
Initial
|
02 February 2024
|
02 February 2029
|
| View |
|
DR-XY48997
|
Voriconazole
|
Vzonale
|
200 mg
|
Lyophilized Powder for Solution for Intravenous
(I.V.) Infusion
|
Triazole and Tetrazole Derivative
|
Kamla Life Sciences Limited
|
India
|
Initial (Reapplication)
|
06 February 2024
|
06 February 2029
|
| View |
|
DR-XY48998
|
Propofol
|
Sedafol
|
10 mg/mL (1% w/v)
|
Emulsion for Intravenous Infusion.
|
General Anesthetic
|
Xi'an Libang Pharmaceutical Co., Ltd.
|
China
|
Initial
|
07 February 2024
|
07 February 2029
|
| View |
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DR-XY48999
|
Valganciclovir (as hydrochloride)
|
VagaCyte
|
450 mg
|
Film-Coated Tablet
|
Antiviral
|
Panacea Biotec Ltd.
|
India
|
Initial
|
11 March 2024
|
11 March 2029
|
| View |
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DR-XY49000
|
ultivitamins + Minerals
|
Elevit Pre-conception
|
Formulation
Each Film-Coated Tablet contains:
Calcium
125 mg
Thiamine Nitrate (Vit B1)
1.73 mg 1.40 mg
100 mg
Riboflavin (Vit B2)
85 mg 44.70 mg
Copper (as Copper sulfate anhydrous) Biotin
] mg
0.03 mg
Cholecalciferol (Vitamin D3)
Vitamin B9 (as L-methylfolate, calcium) Folic acid (Vitamin B9)
lodine (as Potassium Iodide)
Selenium (as Sodium selenite)
Cyanocobalamin (Vitamin B12)
1000 IU
451 mcg
400 mcg
220 mcg
50 mcg 2.60 mcg
Magnesium (as Magnesium oxide heavy)
Ascorbic acid (Vitamin C)
Vitamin E (as dl-a-Tocopherol acetate concentrate)
Iron (as Ferrous bisglycinate)
Nicotinamide
Zinc
Calcium pantothenate (Vitamin B5)
27 mg
18 mg
11 mg
6.52 mg
2.31 mg
Manganese (Manganese Sulfate Monohydrate)
2 mg
Pyridoxine HCl (Vitamin B6)
|
Film-Coated Tablet
|
Multivitamins + Minerals
|
PT. Bayer Indonesia
|
Indonesia
|
Initial [OTC]
|
13 February 2024
|
13 February 2029
|
| View |
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DR-XY49001
|
Levonorgestrel
|
Levoplant
|
75 mg
|
Subdermal Implant
|
Hormonal Contraceptive (Progestogen)
|
Shanghai Dahua Pharmaceutical Co., Ltd. 3503
|
China
|
Monitored Release (Re-application)
|
15 March 2024
|
15 March 2029
|
| View |
|
DR-XY49002
|
Quetiapine (as fumarate)
|
Victus XR
|
300 mg
|
Sustained Release Tablet
|
Antipsychotic
|
Intas Pharmaceuticals Limited
|
India
|
Initial (Re-application)
|
19 February 2024
|
19 February 2029
|