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DR-XY48091_PI_01.pdf
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DR-XY48091
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Neratinib Maleate
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Nerlynx
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40 mg
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Film-Coated Tablet
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Antineoplastic Agent (Protein Kinase Inhibitor)
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Excella GmbH & Co. Kg
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Germany
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Monitored Release
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06 June 2022
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06 June 2027
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| View |
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DR-XY48076
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Montelukast (as sodium) + Levocetirizine hydrochloride
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Molev
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10 mg/ 5 mg
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Film Coated Tablet
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Leukotriene Receptor Antagonist
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Cadila Healthcare Limited
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India
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Initial
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01 June 2022
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01 June 2027
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DRP-12093
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Milrinone
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Milrin
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1 mg/mL (10 mg/10 mL)
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Injection (IV)
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Cardiac Stimulants Excl. Cardiac Glycosides
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PT Pratapa Nirmala
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Indonesia
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Monitored Release
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10 June 2022
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10 June 2027
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DR-XY48094
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Bortezomib
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Mibzo
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3.5 mg
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Lyophilized Powder For Injection
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Antineoplastic Agent (Proteasome Inhibitor)
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MSN Laboratories Private Limited
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India
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Initial
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07 June 2022
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07 June 2027
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DRP-12029
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Letrozole
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Letroday
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2.5 mg
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Film-Coated Tablet
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Antineoplastic (Aromatase Inhibitor)
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Eugia Pharma Specialities Limited
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India
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Initial
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31 May 2022
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31 May 2027
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DRP-12035
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Glibenclamide + Metformin Hydrochloride
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Glynova
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5mg/ 500mg
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Tablet
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Oral hypoglycemic (Sulfonylureas/Biguanides)
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Acme Formulation Pvt. Ltd.
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India
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Initial
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31 May 2022
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31 May 2027
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| View |
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DRP-12037
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Sitagliptin (as phosphate monohydrate) +
Metformin hydrochloride
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Gliptina Plus
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50 mg/1 g
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Film Coated Tablet
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Dipeptidyl peptidase 4 (DPP-4) inhibitor/ Blood glucose lowering drug (Biguanide)
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Sai Mirra Innopharm Pvt. Ltd.
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India
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Initial
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02 June 2022
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02 June 2027
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| View |
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DRP-12059
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Sitagliptin (as Phosphate Monohydrate) + Metformin
Hydrochloride
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Glipstar-1000
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50mg/1g
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Film Coated Tablet
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Oral Hypoglycemic Agent (Dipeptidyl Peptidase 4 (DPP-4) Inhibitor/Biguanide)
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Theon Pharmaceuticals Limited
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India
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Initial
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06 June 2022
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06 June 2027
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| View |
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DRP-12028
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Gefitinib
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Gefivid
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250mg
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Tablet
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Antineoplastic [Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor]
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Qilu Pharmaceutical (Hainan) Co., Ltd.
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China
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Initial
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31 May 2022
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31 May 2027
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| View |
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DRP-12118
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Omeprazole (As Sodium)
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Furecid IV
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40 mg
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Lyophilized Powder for Injection (I.V.)
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Proton Pump Inhibitor
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Furen Pharmaceutical Group Co., Ltd.
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China
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Initial
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14 June 2022
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14 June 2027
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DRP-12133
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Amlodipine (as besilate)
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Docvasc
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5 mg
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Tablet
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Calcium Channel Blocker
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Phil. United Pharma Corporation
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Philippines
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Initial
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17 June 2022
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17 June 2027
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| View |
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DRP-12132
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Amlodipine (as besilate)
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Docvasc
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10 mg
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Tablet
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Calcium Channel Blocker
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Phil. United Pharma Corporation
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Philippines
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Initial
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17 June 2022
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17 June 2027
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| View |
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DR-XY 48110
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Cyproterone Acetate + Ethinylestradiol
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Cypress
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2 mg/35 mcg
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Tablet
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Antiandrogen-Estrogen Combination (Hormonal Contraceptive)
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Mylan Laboratories Ltd.
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India
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Initial
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16 June 2022
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16 June 2027
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DRP-12017
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Co-Amoxiclav
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Clavoxsea 625
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Formulation: (CPR at the back)
Each Tablet contains
Amoxicillin (as trihydrate)
500 mg
Clavulanic Acid (as Clavulanate Potassium) 125 mg
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Film-Coated Tablet
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Antibacterial (Penicillin/Beta-lactamase inhibitor)
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Yeluri Formulations Pvt. Ltd.
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India
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Initial (Correction)
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29 September 2023
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31 May 2027
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| View |
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DRP-12100
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Co-Amoxiclav
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Clavoxsea 457
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457 mg
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Powder for Oral Suspension
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Antibacterial (Penicillin/Beta-lactamase Inhibitor)
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Yeluri Formulations Pvt. Ltd.
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India
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Initial
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10 June 2022
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10 June 2027
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| View |
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DRP-12018
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Co-Amoxiclav
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Clavoxsea 375
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Formulation:
Each Tablet contains
Amoxicillin (as trihydrate)
250 mg
Clavulanic Acid (as Clavulanate Potassium) 125 mg
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Film-Coated Tablet
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Antibacterial (Penicillin/Beta-lactamase inhibitor)
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Yeluri Formulations Pvt. Ltd.
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India
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Initial (Correction)
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29 September 2023
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31 May 2027
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| View |
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DRP-12099
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Co-Amoxiclav
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Clavoxsea 228.5
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228.5 mg
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Powder For Oral Suspension
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Antibacterial (Penicillin/Beta-lactamase inhibitor)
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Yeluri Formulations Pvt. Ltd.
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India
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Initial
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10 June 2022
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10 June 2027
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| View |
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DR-XY48089
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Cisatracurium (as besilate)
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Cistra
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2 mg/mL (10 mg/5 mL)
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Solution for Injection (IV)
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Neuromauscular Blocker
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Jiangsu Hengrui Medicine Co., Ltd.
|
China
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Initial
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03 June 2022
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03 June 2027
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| View |
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DRP-12106
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Lactated Ringer's Solution
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BL RL
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Formulation Each 100 mL contains:
Sodium Lactate Sodium Chloride Potassium Chloride Calcium Chloride
320 mg 600 mg
40 mg 28.35 mg
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Solution for I.V. Infusion
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Fluid Replacement
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Axa Parenterals Ltd.
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India
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Initial
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13 June 2022
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13 June 2027
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| View |
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DR-XY48085
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Bilastine
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Bilaxten
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2.5mg/mL
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Oral Solution
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-
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Berlin-Chemie AG
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Germany
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Monitored Release
|
02 June 2022
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02 June 2027
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