| View |
|
DR-XY48428
|
Vancomycin (as hydrochloride)
|
Vamicyn
|
500 mg
|
Powder for IV Infusion
|
-
|
Furen Pharmaceutical Group Co., Ltd.
|
China
|
Initial
|
18 October 2022
|
18 October 2027
|
| View |
|
DR-XY48429
|
5% Dextrose in Lactated Ringer's Solution
|
None
|
1000mL
|
Solution for Intravenous Infusion
|
Electrolyte Replenisher
|
Shijiazhuang No.4 Pharmaceutical Co., Ltd.
|
China
|
Initial
|
18 October 2022
|
18 October 2027
|
| View |
|
DR-XY48430
|
5% Dextrose in Lactated Ringer's Solution
|
None
|
Formulation: Each 100 mL contains: Anhydrous Dextrose.... ............5g Sodium chloride..................600 mg
Sodium lactate.............................310 mg Potassium chloride..........................30 mg Calcium chloride (dihydrate)...........20 mg
|
Solution for Intravenous Infusion
|
Electrolyte Replenisher
|
Shijiazhuang No.4 Pharmaceutical Co., Ltd.
|
China
|
Initial
|
18 October 2022
|
18 October 2027
|
| View |
|
DR-XY48431
|
Acetylcysteine
|
Solbriz
|
200 mg
|
Powder for Oral Solution
|
Mucolytic
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
26 October 2022
|
26 October 2027
|
| View |
|
DR-XY48432
|
Irbesartan + Hydrochlorothiazide
|
Malatan Plus
|
150 mg/12.5 mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker-Diuretic Combination
|
Genepharm S.A.
|
Greece
|
Initial (Re-application) [Correction]
|
30 January 2023
|
27 October 2027
|
| View |
|
DR-XY48433
|
Irbesartan + Hydrochlorothiazide
|
Malatan Plus
|
300 mg/12,5 mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker-Diuretic Combination
|
Genepharm S.A.
|
Greece
|
Initial (Re-application) [Correction]
|
30 January 2023
|
27 October 2027
|
| View |
|
DR-XY48434
|
Irbesartan + Hydrochlorothiazide
|
Malatan Plus
|
300 mg/25 mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker-Diuretic Combination
|
Genepharm S.A.
|
Greece
|
Initial (Re-application) [Correction]
|
30 January 2023
|
27 October 2027
|
| View |
|
DR-XY48435
|
Abiraterone acetate
|
Abirasun
|
250 mg
|
Tablet
|
Antineoplastic/Immunomodulating Agent (Hormone
Antagonist/Related Agent)
|
Sun Pharmaceutical Industries Limited
|
India
|
Monitored Release (Re-application) (Reconstruction)
|
24 May 2024
|
08 July 2027
|
| View |
|
DR-XY48436
|
Gemcitabine (as hydrochloride)
|
Infusmart
|
10 mg/mL
|
Solution for Injection for I. V. Infusion (Ready-to-Infuse)
|
Antineoplastic Agent (Pyrimidine Analogue)
|
Sun Pharmaceutical Industries Limited
|
India
|
Monitored Release (MR) (Reconstruction)
|
24 May 2024
|
27 October 2027
|
| View |
|
DR-XY48437
|
Voriconazole
|
Vorix
|
200mg
|
Lyophilized Powder for Injection (IV Infusion)
|
Antimycotics for systemic use (Triazole and tetrazole derivative)
|
Centurion İlaç Sanayi ve Ticaret A.Ş.Ankara Şubesi
|
Turkey
|
Initial
|
27 October 2022
|
27 October 2027
|
| View |
|
DR-XY48438
|
Nicotine
|
2baconil TTS30
|
21 mg/24 hrs. (52.5 mg/30 cm2)
|
Transdermal Patch
|
Drug Used in Nicotine Dependence
|
Rusan Pharma Limited
|
India
|
Monitored Release
|
28 October 2022
|
28 October 2027
|
| View |
|
DR-XY48439
|
Nicotine
|
2baconil TTS20
|
14 mg/24 hrs. (35 mg/20 cm2)
|
Transdermal Patch
|
Drug Used in Nicotine Dependence
|
Rusan Pharma Limited
|
India
|
Monitored Release
|
28 October 2022
|
28 October 2027
|
| View |
|
DR-XY48440
|
Nicotine
|
2baconil TTS10
|
7 mg/24 hrs. (17.5 mg/ 10 cm2)
|
Transdermal Patch
|
Drug Used in Nicotine Dependence
|
Rusan Pharma Limited
|
India
|
Monitored Release
|
28 October 2022
|
28 October 2027
|
| View |
|
DR-XY48441
|
Simvastatin + Ezetimibe
|
Stadavas Plus
|
80 mg/ 10 mg
|
Tablet
|
Lipid Modifying Agents
|
Watson Pharma Pvt. Ltd.
|
India
|
Monitored Release
|
28 October 2022
|
28 October 2027
|
| View |
|
DR-XY48442
|
Leflunomide
|
Lefno
|
20 mg
|
Film-Coated Tablet
|
Immunosuppresant
|
Kusum Healthcare Pvt. Ltd
|
India
|
Monitored Release
|
28 October 2022
|
28 October 2027
|
| View |
DR-XY48443_PI_01.pdf
|
DR-XY48443
|
Tioconazole + Tinidazole + Lidocaine
|
Neopenmax XL
|
300 mg/ 200 mg/ 100 mg
|
Vaginal Suppository
|
Antibacterial (Imidazole)/ Antifungal/ Local Anesthetic
|
Exeltis İlaç San. Ve Tic. A.Ş.
|
Turkey
|
Monitored Release
|
28 October 2022
|
28 October 2027
|
| View |
|
DR-XY48444
|
Rosuvastatin (as calcium)
|
Rosukon-10
|
10 mg
|
Film-Coated Tablet
|
HMG COA Reductase Inhibitor
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial
|
28 October 2022
|
28 October 2027
|
| View |
DR-XY48445_PI_01.pdf
|
DR-XY48445
|
Lurasidone (as Hydrochloride)
|
Lurata 80
|
80mg
|
Film-Coated Tablet
|
Antipsychotic
|
MSN Laboratories Private Limited
(Formulations Division)
|
India
|
Monitored Release
|
28 October 2022
|
28 October 2027
|
| View |
|
DR-XY48446
|
Multivitamins + Herbs + Inositol + Choline
|
None
|
Formulation Each capsule contains: Thiamine Mononitrate (Vitamin B1)-50mg Riboflavin (Vitamin B2)-50mg Niacinamide (Vitamin B3)-50mg Pyridoxine Hydrochloride (Vitamin B6)-50mg Folic Acid (Vitamin B9)-400mcg Cyanocobalamin (Vitamin B12)-50mcg Biotin (Vitamin B7)-50 mcg Pantothenic Acid (Vitamin B5)-50mcg Inositol-50 mg Choline (Choline Bitartrate)-21mg
Herbal Powdered Blend contains:
3.5mg Laminaria digitata (Kelp) Plant Malpighia emarginata (Acerola Extract Complex) Fruit Medicago sativa (Alfalfa) Leaf and Stem Petroselimm crispum (Parsley) Stem) Rosa acicularis Lindi (Rose Hips) Fruit Nasturtium officinale (Watercress) Herb
|
Capsule
|
-
|
Solgar, Inc.
|
United States of America
|
Initial (OTC)
|
28 October 2022
|
28 October 2027
|
| View |
|
DR-XY48447
|
Cimicifuga racemosa L. (Black Cohosh) Rhizome
|
Remifemin
|
2.5mg
|
Tablet
|
Non-Hormonal Gynecologic Phytomedicine
|
Schaper & Brümmer GmbH & Co. KG
|
Germany
|
Initial (OTC)
|
28 October 2022
|
28 October 2027
|