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DR-XY48284_PI_01.pdf
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DR-XY48284
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Lamivudine + Tenofovir disoproxil Fumarate + Dolutegravir (as sodium)
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Acriptega
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300 mg/300 mg/50 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
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07 March 2023
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15 August 2027
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DRP-12460
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Losartan Potassium
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None
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50 mg
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Film-Coated Tablet
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Angiotensin II Receptor Blocker
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Unique Pharmaceutical Laboratories (A Division of J.B.
Chemicals & Pharmaceuticals Limited)
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India
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Initial
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12 August 2022
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12 August 2027
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DR-XY48282
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Oseltamivir (as phosphate)
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Oselvir
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75mg
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Capsule
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Antiviral (Neuraminidase inhibitor)
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The Government Pharmaceutical Organization
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Thailand
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Initial (Correction)
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26 January 2023
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15 August 2027
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DR-XY48278
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Erdosteine
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Vostrin
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300mg
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Capsule
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Mucolytic
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PT. Novell Pharmaceutical Laboratories
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Indonesia
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Initial
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11 August 2022
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11 August 2027
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DRP-12458
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Lactulose
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Easylac
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3.35 g/5 mL
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Oral Solution
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-
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Panacea Biotec Ltd.
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India
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Initial
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12 August 2022
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12 August 2027
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DRP-12462
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Quetiapine (As Fumarate)
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Qutero 300
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300mg
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Film-Coated Tablet
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-
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Hetero Labs Limited (Unit-V, Block-VB)
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India
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Initial
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11 August 2022
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11 August 2027
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DR-XY48279
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Lactulose
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Lactusol
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3.35g/5mL
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Oral Solution
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Osmotically Acting Laxative
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KCK Pharmaceutical Industries Sdn. Bhd.
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Malaysia
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Initial
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12 August 2022
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12 August 2027
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| View |
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DR-XY48280
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Solifenacin Succinate
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Abo 5
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5 mg
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Film-Coated Tablet
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-
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Unison Laboratories Co., Ltd.
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Thailand
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Initial
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15 August 2022
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15 August 2027
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| View |
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DRP-12459
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Bendamustine Hydrochloride
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Chronistin
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2.5 mg/mL (25 mg and 100 mg)
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Lyophilized Powder for Concentrate Solution for IV Infusion
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Antineoplastic Agent (Nitrogen Mustard Analogue)
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Oncomed Manufacturing A.S.
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Czech Republic
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Initial
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12 August 2022
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12 August 2027
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| View |
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DRP-12461
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Cefepime (as Hydrochloride)
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Sefepi 1000
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1 g
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Powder for Injection (I.M./I.V.)
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Cephalosporin
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Sakar Healthcare Pvt. Ltd.
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India
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Initial
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11 August 2022
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11 August 2027
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| View |
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DR-XY48275
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Docetaxel
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Hexcet
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80 mg/2 mL
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Concentrate for Solution for IV Infusion
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Antineoplastic
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SP Accure Labs Pvt. Ltd.
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India
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Initial
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11 August 2022
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11 August 2027
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| View |
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DR-XY48274
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Docetaxel
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Docebil
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80 mg/ 2 mL
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Concentrate for Solution for (IV) Infusion
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Antineoplastic
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SP Accure Labs Pvt. Ltd.
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India
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Initial
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12 August 2022
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12 August 2027
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| View |
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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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| View |
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DRP-7192
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Letrozole
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Lezol
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2.5mg
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Film-Coated Tablet
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-
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Intas Pharmaceuticals Limited
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India
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Automatic Renewal (Correction)
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12 August 2022
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11 October 2025
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| View |
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DRP - 1200
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Carnitine Orotate + Hepatic Extract Antitoxic Fraction
+ Adenine HCI + Pyridoxine HCl + Riboflavin + Cyanocobalamin
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Godex DS
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300 mg/25 mg/5 mg/50 mg/1 mg/ 250 mcg
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Capsule
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-
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Celltrion Pharm Inc.
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Korea
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Automatic Renewal (Correction)
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12 August 2022
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03 April 2025
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| View |
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DR-XY48273
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Oxaliplatin
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Platixel
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5mg/mL
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Concentrate for Solution For I.V. Infusion
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Antineoplastic Agent
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Sichuan Huiyu Pharmaceutical Company Limited
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China
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Initial
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15 August 2022
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15 August 2027
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| View |
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DR-XY42590
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Moxifloxacin Hydrochloride
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Vistamox
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5 mg/mL (0.50% w/v)
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Ophthalmic Solution (Drops)
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Antibacterial
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EL Laboratories, Inc
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Philippines
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-
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21 September 2021
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07 October 2025
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| View |
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DR-XY37706
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Calcium + Vitamin D + Minerals
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Caltrate Plus
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[see reverse]
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Film-Coated Tablet
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Vitamin and Minerals
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Wyeth Pharmaceutical Co. Ltd.
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China
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Automatic Renewal
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31 July 2021
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29 March 2025
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| View |
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DRP-3135-02
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Levofloxacin (as Hemihydrate)
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Levolife 500
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500 mg
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Film-Coated Tablet
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Antibacterial
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Agio Pharmaceuticals Limited
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India
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Automatic Renewal
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17 July 2021
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17 November 2026
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| View |
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DRP-108-03
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Metronidazole
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Forazole-IV
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5 mg/mL (500 mg/100 mL)
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Solution for Injection (IV)
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Antibacterial (Imidazole Derivative)
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Taiwan Biotech Co., Ltd.
|
China
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-
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16 July 2021
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18 August 2026
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