| View |
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DR-XY47797
|
Chlormadinone acetate + Ethinylestradiol
|
Belara
|
2mg/ 30mcg
|
Film-Coated Tablet
|
-
|
Gedeon Richter Plc.
|
Hungary
|
-
|
04 May 2022
|
15 March 2027
|
| View |
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DR-XY47799
|
Lactulose
|
Lactowyn
|
10g/15mL
|
Oral Solution
|
Laxatives/ Cathartics
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial
|
26 May 2022
|
10 March 2027
|
| View |
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DR-XY47800
|
Carboplatin
|
Stricarb
|
10 mg/mL (150 mg/15 mL)
|
Solution for Infusion (IV)
|
Antineoplastic agents
|
Mylan Laboratories Limited-OTL
|
India
|
Initial
|
10 March 2022
|
10 March 2027
|
| View |
DR-XY47801_PI_01.pdf
|
DR-XY47801
|
Valporic Acid
|
Vallepsy
|
250 mg5/mL
|
Syrup
|
Anticonvulsant
|
PT. Novell Pharmaceutical Laboratories
|
Indonesia
|
Initial
|
11 March 2022
|
11 March 2027
|
| View |
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DR-XY47802
|
Acetylcysteine
|
None
|
600 mg
|
Film-Coated Tablet
|
Mucolytic
|
Amherst Laboratories, Inc.
|
Philippines
|
Initial
|
10 March 2022
|
10 March 2027
|
| View |
|
DR-XY47803
|
Acetylcysteine
|
Exflem
|
600 mg
|
Film-Coated Tablet
|
Mucolytic
|
Amherst Laboratories, Inc.
|
Philippines
|
Initial
|
10 March 2022
|
10 March 2027
|
| View |
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DR-XY47804 (For Export Only)
|
Acetylcysteine
|
None
|
600 mg
|
Film-Coated Tablet
|
Mucolytic
|
Amherst Laboratories, Inc.
|
Philippines
|
Initial
|
10 March 2022
|
10 March 2027
|
| View |
|
DR-XY47805 (For Export Only)
|
Acetylcysteine
|
Exflem
|
600 mg
|
Film-Coated Tablet
|
Mucolytic
|
Amherst Laboratories, Inc.
|
Philippines
|
Initial
|
10 March 2022
|
10 March 2027
|
| View |
|
DR-XY47808
|
Hemodialysis and Hemofiltration Solution
|
Prismasol BO
|
Formulation: Electrolyte Solution in Small Compartment (250 mL) Each L contains: Lactic acid
5.40 g Calcium chloride
5.145 g Magnesium chlroride
2.033 g
Buffer Solution in Large Compartment (4.75 L) Each L contains: Sodium chloride 6.45 g Sodium bicarbonate 3.09 g
|
Solution for Hemodialysis and Hemofiltration
|
Hemodialysis/Hemofiltration Solution
|
Bieffe Medital S.p.A.
|
Italy
|
Initial
|
11 March 2022
|
11 March 2027
|
| View |
|
DR-XY47809
|
Testosterone
|
Androgel
|
16.2 mg/g (1.62% w/w)
|
Transdermal Gel
|
-
|
Laboratoire Besins International
|
France
|
Monitored Release
|
11 March 2022
|
11 March 2027
|
| View |
|
DR-XY47810
|
Paracetamol + Phenylpropanolamine Hydrochloride +
Chlorphenamine Maleate
|
Symdex-D
|
325 mg/25 mg/2 mg
|
Tablet
|
Analgesic/Antipyretic/Nasal Decongestant/Antihistamine
|
Allied Pharmaceutical Laboratories Inc.
|
Philippines
|
Initial (OTC)
|
28 April 2022
|
16 March 2027
|
| View |
|
DR-XY47811
|
Hydrocortisone (as sodium succinate)
|
None
|
100 mg
|
Powder for Injection (I.M./I.V.)
|
Corticosteroid
|
Karnataka Antibiotics & Pharma Ltd.
|
India
|
Initial
|
11 March 2022
|
11 March 2027
|
| View |
|
DR-XY47812
|
Multivitamins + Iron
|
None
|
Each capsule contains: Ascorbic Acid (Vitamin C) Pyridoxine HCl (Vitamin B6) Folic Acid (Vitamin B9) Cobalamin (Vitamin B12) Iron (Ferrous Fumarate)
60mg
10mg 400mcg 250mcg
29mg
|
Capsule
|
Vitamin/Mineral
|
Nexgen Pharma Inc.
|
United States of America
|
Initial
|
11 March 2022
|
11 March 2027
|
| View |
|
DR-XY47813
|
Sterile Water For Injection
|
None
|
50mL and 100mL
|
Solution for Injection
|
Solvent/Diluent
|
Shijiazhuang No.4 Pharmaceutical Co., Ltd.
|
China
|
Initial
|
14 March 2022
|
14 March 2027
|
| View |
|
DR-XY47814
|
Aceclofenac
|
Aceclo-X
|
100mg
|
Film Coated Tablet
|
Non-steroidal Anti-Inflammatory (Acetic Acid Derivative)
|
Zim Laboratories Limited
|
India
|
Initial
|
14 March 2022
|
14 March 2027
|
| View |
DR-XY47815_PI_01.pdf
|
DR-XY47815
|
Cefotaxime (As sodium)
|
Sitixime
|
1 g
|
Powder For Injection (IM/IV)
|
Antibacterial (Cephalosporin)
|
Zhuhai Kinhoo Pharmaceutical Co., Ltd.
|
China
|
Initial
|
15 March 2022
|
15 March 2027
|
| View |
|
DR-XY47816
|
Clopidogrel (as bisulfate)
|
Anticlop
|
75mg
|
Film Coated Tablet
|
Antithrombotic Agent (Platelet Aggregation Inhibitor)
|
Zim Laboratories Limited
|
India
|
Initial
|
14 March 2022
|
14 March 2027
|
| View |
|
DR-XY47817
|
Montelukast (As Sodium)
|
Montela 10
|
10mg
|
Film-Coated Tablet
|
Leukotriene Receptor Antagonist
|
Delta Pharma Ltd.
|
Bangladesh
|
Initial (Reconstruction)
|
14 July 2022
|
14 March 2027
|
| View |
|
DR-XY47818
|
Ceftazidime (as pentahydrate)
|
Cefedix
|
1g
|
Powder for Injection (IM/IV)
|
Antibacterial (Third Generation Cephalosporin)
|
Scott-Edil Advance Research Laboratories &
Education Limited
|
India
|
Initial
|
15 March 2022
|
15 March 2027
|
| View |
|
DR-XY47819
|
Metronidazole
|
Frotin
|
250 mg
|
Vaginal Suppository
|
-
|
Y.S.P. Industries (M) SDN. BHD.
|
Malaysia
|
-
|
15 March 2022
|
15 March 2027
|