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DR-XY48285_PI_01.pdf
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DR-XY48285
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Dolutegravir (as sodium) + Emtricitabine + Tenofovir
alafenamide (as fumarate)
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Kocitaf
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50 mg/200 mg/25 mg
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Film-Coated Tablet
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Direct Acting Antiviral
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Mylan Laboratories Limited
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India
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Monitored Release (Reconstruction)
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07 March 2023
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15 August 2027
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DR-XY48286
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Haloperidol Decanoate
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Seredol Deca
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50mg/mL
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Solution for Injection (IM)
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Antipsychotic
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Atlantic Laboratories Corp., Ltd.
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Thailand
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Initial [Rx]
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16 August 2022
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16 August 2027
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DR-XY48287
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Fenofibric Acid
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None
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35 mg
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Softgel Capsule
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Lipid Modifying Agent
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Amherst Laboratories, Inc.
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Philippines
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Monitored Release (Re-application)
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15 August 2022
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15 August 2027
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DR-XY48290
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Montelukast (as sodium) + Levocetirizine hydrochloride
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Monvex-L
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10 mg / 5 mg
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Tablet
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-
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West Coast Pharmaceutical Works Ltd.
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India
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Initial (Re-application)
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15 August 2022
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15 August 2027
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DR-XY48291
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Atorvastatin (as Calcium) + Fenofibrate
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Fenostat
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40 mg/160 mg
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Film-Coated Tablet
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-
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Ajanta Pharma Limited
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India
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Monitored Release
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15 August 2022
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15 August 2025
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DR-XY48292
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Carboplatin
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Carbobil
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10 mg/mL (450 mg/45 mL)
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Concentrate for Solution
for Intravenous (IV) infusion
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Antineoplastic agent
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SP Accure Labs Pvt. Ltd.
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India
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Initial
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17 August 2022
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17 August 2027
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DR-XY48293
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Carboplatin
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Carbohex
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10 mg/mL (450 mg/45 mL)
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Concentrate for Solution for Intravenous (IV) Infusion
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Antineoplastic agent
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SP Accure Labs Pvt. Ltd.
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India
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Initial
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17 August 2022
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17 August 2027
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| View |
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DR-XY48294
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Carboplatin
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Hexplatin
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10 mg/mL (150 mg/15 mL)
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Concentrate for Solution
for Intravenous (IV) Infusion
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Antineoplastic agent
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SP Accure Labs Pvt. Ltd.
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India
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Initial
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17 August 2022
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17 August 2027
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| View |
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DR-XY48295
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Carboplatin
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Carbobil
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10 mg/mL (150 mg/15 mL)
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Concentrate for Solution
for Intravenous (IV) Infusion
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Antineoplastic agent
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SP Accure Labs Pvt. Ltd.
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India
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Initial
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17 August 2022
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17 August 2027
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| View |
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DR-XY48296
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Goserelin (as acetate)
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Seterus
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3.6 mg
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Implant in Pre-filled Syringe for Subcutaneous (SC) Injection
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-
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AMW GmbH
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Germany
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Initial
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17 August 2022
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17 August 2027
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| View |
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DR-XY48297
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Goserelin (as acetate)
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Seterus
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10.8 mg
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Implant in Pre-filled Syringe for Subcutaneous (SC) Injection
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Gonadotropin Releasing Hormone Analogue
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AMW GmbH
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Germany
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Initial
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17 August 2022
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17 August 2027
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DR-XY48298
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Rasagiline (as mesilate)
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Rasator 0.5
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500 mcg
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Tablet
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-
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Torrent Pharmaceuticals Ltd.
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India
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Monitored Release
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18 August 2022
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18 August 2025
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| View |
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DR-XY48299
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Oseltamivir (as phosphate)
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Tamiselvir
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75 mg
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Capsule
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Antiviral (Neuraminidase Inhibitor)
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Korea United Pharm. Inc.
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Korea
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Initial
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19 August 2022
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19 August 2027
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| View |
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DR-XY48300
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Pantoprazole (As Sodium Sesquihydrate)
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Conpanzole
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20 mg
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Enteric-Coated Tablet
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Proton Pump Inhibitor
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Y.S.P. Industries (M) Sdn. Bhd.
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Malaysia
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Initial
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18 August 2022
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18 August 2027
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DR-XY48301
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Cinacalcet (as hydrochloride)
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None
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30 mg
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Film-Coated Tablet
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Anti-parathyroid Agent
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Lloyd Laboratories, Inc.
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Philippines
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Monitored Release (correction)
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18 August 2022
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22 November 2024
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DR-XY48302
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Cinacalcet (as hydrochloride)
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None
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90 mg
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Film-Coated Tablet
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Anti-parathyroid Agent
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Lloyd Laboratories, Inc.
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Philippines
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Monitored Release (MR) (Reissuance) correction
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18 August 2022
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22 November 2024
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| View |
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DR-XY48303
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Cinacalcet (as hydrochloride)
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None
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60 mg
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Film-Coated Tablet
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Anti-parathyroid Agent
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Lloyd Laboratories, Inc.
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Philippines
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Monitored Release (MR) (Reissuance) correction
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18 August 2022
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22 November 2024
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| View |
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DR-XY48304
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Cetirizine Hydrochloride
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Simtec
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10mg
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Tablet
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Antihistamine
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Duopharma Manufacturing (Bangi) Sdn. Bhd.
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Malaysia
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Initial (OTC)
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19 August 2022
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19 August 2027
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| View |
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DR-XY48305
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Losartan Potassium + Hydrochlorothiazide
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Saranto- H
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50mg/12.5mg
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Film -Coated Tablet
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Angiotensin II Receptor blocker (ARB)/ Diuretic
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Aurobindo Pharma Limited (Unit III)
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India
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Initial (Re-application)
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19 August 2022
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19 August 2027
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| View |
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DR-XY48306
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Piracetam
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Embol
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200 mg/mL
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Solution For Injection (IM/IV)
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Nootropics
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Y.S.P. Industries (M) SDN. BHD.
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Malaysia
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Initial (Re-application)
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22 August 2022
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22 August 2027
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