| View |
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DR-XY47774
|
Zonisamide
|
Zoresan®
|
25 mg
|
Capsule
|
Antiepileptic
|
Kusum Healthcare Pvt. Ltd.
|
India
|
Monitored Release
|
04 March 2022
|
04 March 2027
|
| View |
|
DR-XY47775
|
Ascorbic Acid + Citrus Bioflavonoid Complex +
Rosa canina (Rose Hips) Fruit
|
None
|
500mg/25mg/14mg
|
Caplet
|
Vitamin
|
NBTY Manufacturing, LLC
|
United States of America
|
Initial
|
07 March 2022
|
07 March 2025
|
| View |
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DR-XY47776
|
Cholecalciferol
|
None
|
60,000 IU
|
Chewable Tablet
|
Vitamin
|
Tirupati Medicare Limited
|
India
|
Initial
|
04 March 2022
|
04 March 2027
|
| View |
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DR-XY47777
|
Adapalene + Clindamycin (as phosphate)
|
Acnex
|
1 mg/10 mg (0.1% w/w/1.0 w/w) per g
|
Topical Gel
|
Anti-Acne
|
Kusum Healthcare Pvt. Ltd.
|
India
|
Initial
|
07 March 2022
|
07 March 2027
|
| View |
|
DR-XY47778
|
Amlodipine (as besilate) + Valsartan
|
Exnin
|
10 mg/ 160 mg
|
Film Coated Tablet
|
Angiotensin II Receptor Blocker + Calcium Channel
Blocker
|
Myungmoon Pharmaceutical Co., Ltd.
|
Korea
|
Initial
|
08 March 2022
|
08 March 2027
|
| View |
|
DR-XY47779
|
Ambroxol Hydrochloride
|
Expesyl
|
30 mg
|
Tablet
|
Mucolytic
|
Pharmatechnica Laboratory, Inc.
|
Philippines
|
Initial (OTC) (Reconstruction)
|
16 January 2024
|
07 March 2027
|
| View |
|
DR-XY47780
|
Lutein + Zeaxanthin
|
Maxanthin AREDS2
|
10mg / 2mg
|
Softgel Capsule
|
Vitamins
|
Softgel Healthcare Pvt. Ltd.
|
India
|
Automatic Renewal (E-AR)
|
27 February 2024
|
07 March 2029
|
| View |
|
DR-XY47781
|
Pantoprazole (as sodium)
|
Pantonil
|
40 mg
|
Lyophilized Powder for Injection (IV)
|
Proton Pump Inhibitor
|
Mefar Ilaç Sanayii A.Ş.
|
Turkey
|
Initial
|
07 March 2022
|
07 March 2027
|
| View |
|
DR-XY47782
|
Magnesium
|
None
|
500 mg
|
Tablet
|
Vitamin
|
Factors Group of Nutritional Companies Inc.
|
Canada
|
Initial
|
08 March 2022
|
08 March 2027
|
| View |
|
DR-XY47783
|
Retinyl Palmitate (Vitamin A)
|
None
|
25,000 IU
|
Softgel Capsule
|
Vitamin
|
Now Foods
|
United States of America
|
Initial
|
08 March 2022
|
08 March 2027
|
| View |
|
DR-XY47784
|
Dexmedetomidine (as hydrochloride)
|
Predex
|
100 mcg/mL (200 mcg/2 mL)
|
Concentrate for Solution for Infusion (IV)
|
Hypnotic/Sedative
|
Themis Medicare Limited
|
India
|
Monitored Release
|
08 March 2022
|
08 March 2027
|
| View |
|
DR-XY47786
|
Rosuvastatin (as calcium)
|
Rozutor
|
20 mg
|
Film- Coated Tablets
|
Lipid Modifying Agent (HMG COA
inhibitor)
|
Elpen Pharmaceutical Co., Inc.
|
Greece
|
Initial
|
08 March 2022
|
08 March 2027
|
| View |
|
DR-XY47787
|
Rosuvastatin (as calcium)
|
Rozutor
|
10 mg
|
Film- Coated Tablet
|
Lipid Modifying Agent (HMG CoA
inhibitor)
|
Elpen Pharmaceutical Co., Inc.
|
Greece
|
Initial
|
08 March 2022
|
08 March 2027
|
| View |
|
DR-XY47789
|
Hexylresorcinol
|
Difflam H-extraTM
|
2.4mg
|
Lozenge (Purple Grape Flavor)
|
Antiseptic
|
Unique Pharmaceutical Laboratories (Division of J.B.
Chemicals & Pharmaceuticals Ltd.)
|
U.A.E.
|
Initial
|
08 March 2022
|
08 March 2027
|
| View |
|
DR-XY47790
|
Efavirenz
|
None
|
600 mg
|
tablet
|
Antiviral (Non-Nucleoside Reverse Transcriptase
Inhibitor)
|
Micro Labs Limited
|
India
|
Monitored Release
|
08 March 2022
|
08 March 2027
|
| View |
|
DR-XY47791
|
Carboplatin
|
Ovatin
|
10 mg/mL (150 mg/15 mL)
|
Solution for I.V. Infusion (I. V.)
|
Antineoplastic agents
|
Venus Remedies Limited
|
India
|
Initial
|
08 March 2022
|
08 March 2027
|
| View |
|
DR-XY47792
|
Esomeprazole (As Sodium)
|
None
|
40mg
|
Lyophilized Powder For I.V. Injection & Infusion
|
Proton Pump Inhibitor
|
Getz Pharma Pvt. Ltd.
|
Pakistan
|
Initial
|
10 March 2022
|
10 March 2027
|
| View |
DR-XY47793_PI_01.pdf
|
DR-XY47793
|
Levetiracetam
|
Leveget
|
100 mg/mL (500 mg/5 mL)
|
Solution for Injection (IV)
|
Antiepileptic
|
Getz Pharma Pvt. Ltd.
|
Pakistan
|
Initial
|
10 March 2022
|
10 March 2027
|
| View |
|
DR-XY47794
|
Acetylcysteine
|
Actein
|
100 mg
|
Granules for Solution (Orange Flavor)
|
Mucolytic
|
U-Liang Pharmaceutical Co., Ltd.
|
Taiwan
|
Initial
|
09 March 2022
|
09 March 2027
|
| View |
|
DR-XY47795
|
Clotrimazole
|
Canesten®
|
500mg
|
Vaginal Tablet
|
Antifungal (Imidazole and Triazole derivative)
|
Haupt Pharma Wülfing GmbH Ex: Wülfing Pharma GmbH
|
Germany
|
Initial
|
29 April 2022
|
09 March 2027
|