View |
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DR-XY45941
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Ascorbic Acid (as Calcium Ascorbate and Sodium Ascorbate)
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None
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500mg
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Capsule
|
Vitamin
|
Am-Europharma Corporation-Branch
|
Philippines
|
Renewal
|
20 May 2022
|
10 July 2027
|
View |
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DR-XY45942
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Pyridoxine (as hydrochloride)
|
Vomifree
|
25mg
|
Lozenge
|
Anti-emetic
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Amherst Laboratories, Inc.
|
Philippines
|
Renewal
|
28 April 2022
|
27 June 2027
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View |
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DR-XY45943
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Ciprofloxacin (as Hydrochloride)
|
Sitiflox
|
500mg
|
Film-Coated Tablet
|
Antibacterial (Quinolone)
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Zhejiang Jingxin Pharmaceutical Co., Ltd.
|
China
|
Renewal
|
26 May 2022
|
29 June 2027
|
View |
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DR-XY45944
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Montelukast (as sodium) + Levocetirizine dihydrochloride
|
Stelix
|
10 mg/5 mg
|
Film-Coated Tablet
|
Leukotriene Receptor Antagonist/Antihistamine
|
Bafna Pharmaceuticals Limited
|
India
|
Initial [from Monitored Release]
|
17 October 2022
|
03 July 2027
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View |
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DR-XY45945
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Montelukast (as sodium) + Levocetirizine hydrochloride
|
Velsta
|
10mg/ 5mg
|
Film-Coated Tablet
|
Leukotriene Receptor Antagonist
|
Bafna Pharmaceuticals Limited
|
India
|
Initial (from Monitored Release)
|
05 July 2022
|
03 July 2027
|
View |
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DR-XY45946
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Montelukast (as sodium) + Levocetirizine dihydrochloride
|
Molev
|
10mg/ 5mg
|
Film-Coated Tablet
|
Leukotriene Receptor Antagonist/Antihistamine
|
Bafna Pharmaceuticals Limited
|
India
|
Initial from Monitored - Release]
|
17 October 2022
|
03 July 2027
|
View |
DR-XY45947_PI_01.pdf
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DR-XY45947
|
Netupitant + Palonosetron (as HCI)
|
Akynzeo
|
300 mg/500 mcg
|
Capsule
|
5HT3 Antagonist
|
Helsinn Birex Pharmaceuticals Limited.
|
Ireland
|
Initial (from Monitored Release)
|
04 June 2024
|
04 June 2029
|
View |
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DR-XY45948
|
GANCICLOVIR
|
XOVIRAL
|
1.5mg/ g (0.15% w/ w) (5g tube)
|
Sterile Ophthalmic Solution
|
Antiviral
|
Aristopharma Ltd.
|
Bangladesh
|
Renewal
|
31 May 2022
|
10 July 2027
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View |
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DR-XY45949
|
Ascorbiv Acid
|
Vista C Supreme
|
444.50 mg Capsule (equivalent to 500 mg sodium ascorbate)
|
Capsule
|
-
|
Doctors Pharmaceuticals, Inc.
|
Philippines
|
-
|
15 November 2021
|
10 July 2025
|
View |
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DR-XY45952
|
Ascorbic Acid + Zinc
|
Ceelin Plus Chewables
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Formulation: Each chewable tablet contains:
Ascorbic Acid-20mg Ascorbic Acid (equivalent to 90 mg Sodium Ascorbate)-80mg Zinc (equivalent to Zinc Citrate Trihydrate)-10mg
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Chewable Tablet
|
Vitamin/Mineral
|
United Laboratories, Inc.
|
Philippines
|
Renewal
|
24 June 2022
|
04 July 2027
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View |
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DR-XY45953
|
Amlodipine besilate
|
Norvasc
|
2.5mg
|
Tablet
|
Antihypertensive/Calcium Channel Blocker
|
Pfizer Global Supply Japan Inc.
|
Japan
|
Automatic Renewal
|
21 March 2022
|
17 July 2027
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View |
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DR-XY45960
|
Clopidogrel (as Bisulfate)
|
Gropid
|
75mg
|
Film-Coated Tablet
|
Antithrombotic (Antiplatelet)
|
J. Duncan Healthcare Pvt. Ltd.
|
India
|
Renewal
|
20 June 2022
|
13 July 2027
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View |
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DR-XY45961
|
Chlorphenamine maleate
|
Lorecare
|
10 mg/mL
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Solution for Injection (I.M./I.V./S.C.)
|
H1- Receptor Antagonist (Antihistamine)
|
Suicheng Pharmaceutical Co., Ltd.
|
China
|
Initial (Variation)
|
08 May 2024
|
08 May 2029
|
View |
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DR-XY45962
|
Ceftriaxone Sodium + Sulbactam Sodium
|
Atriax Plus
|
1g/ 500mg
|
Powder for Solution for Injection (IV/IM)
|
Antibacterial (Third-Generation Cephalosporins)
|
Sance Laboratories Pvt. Ltd.
|
India
|
Renewal
|
16 May 2022
|
26 July 2027
|
View |
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DR-XY45963
|
Phospholipids
|
Essentiale Max
|
600mg
|
Capsule
|
Hepatoprotector
|
A. Natterman & Cie. GmbH
|
Germany
|
Automatic Renewal
|
08 July 2022
|
21 July 2027
|
View |
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DR-XY45964
|
Imatinib (as Mesilate)
|
Cytonib 400
|
400 mg
|
Film-Coated Tablet
|
Antineoplastic
|
Hetero Labs Limited (Unit VI)
|
India
|
Renewal
|
19 May 2024
|
12 July 2029
|
View |
DR-XY45966_PI_01.pdf
|
DR-XY45966
|
Ledipasvir + Sofosbuvir
|
Ledvir
|
90 mg / 400 mg
|
Film-Coated Tablet
|
Direct-Acting Antiviral
|
Mylan Laboratories Limited
|
India
|
Initial (from Monitored Release)
|
11 July 2024
|
17 July 2027
|
View |
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DR-XY45967
|
Cefalexin Monohydrate
|
Ceplenext
|
125mg/ 5mL
|
Powder for Suspension
|
Antibacterial (First Generation Cephalosporins)
|
Azarias Pharmaceutical Laboratories, Inc.
|
Philippines
|
Automatic Renewal
|
21 July 2022
|
21 July 2027
|
View |
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DR-XY45968
|
Cefalexin Monohydrate
|
Ceplenext
|
250mg/ 5mL
|
Powder for Suspension
|
Antibacterial (First Generation Cephalosporins)
|
Azarias Pharmaceutical Laboratories, Inc.
|
Philippines
|
Automatic Renewal
|
18 July 2022
|
21 July 2027
|
View |
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DR-XY45969
|
Cefalexin (as monohydrate)
|
Ceplenext
|
100 mg/mL
|
Powder for Suspension for Oral Drops
|
Antibacterial (First Generation Cephalosporins)
|
AZARIAS PHARMACEUTICAL LABORATORIES INC.
|
Philippines
|
Renewal
|
18 July 2022
|
21 July 2027
|