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Approved Drug Products containing Levocetirizine Dihydrochloride listed in the FDA Orange Book. Original Data : FDA Website

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01 1DR REDDYS

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03 1GRANULES

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05 1APOTEX INC

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

RLD : No

TE Code :

LEVOCETIRIZINE DIHYDROCHLORIDE

Brand Name : LEVOCETIRIZINE DIHYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Approval Date : 2018-01-19

Application Number : 210375

RX/OTC/DISCN : OTC

RLD : No

TE Code :

Dr Reddy Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

RLD : No

TE Code :

LEVOCETIRIZINE DIHYDROCHLORIDE

Brand Name : LEVOCETIRIZINE DIHYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Approval Date : 2013-03-26

Application Number : 90486

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Granules India

03

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LEVOCETIRIZINE DIHYDROCHLORIDE

Brand Name : LEVOCETIRIZINE DIHYDROCHLORIDE

Dosage Form : SOLUTION;ORAL

Dosage Strength : 2.5MG/5ML

Approval Date : 2013-07-26

Application Number : 202673

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

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04

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LEVOCETIRIZINE DIHYDROCHLORIDE

Brand Name : XYZAL

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2007-05-25

Application Number : 22064

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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05

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LEVOCETIRIZINE DIHYDROCHLORIDE

Brand Name : XYZAL

Dosage Form : SOLUTION;ORAL

Dosage Strength : 2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2008-01-28

Application Number : 22157

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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06

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LEVOCETIRIZINE DIHYDROCHLORIDE

Brand Name : LEVOCETIRIZINE DIHYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Approval Date : 2011-02-24

Application Number : 90385

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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07

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LEVOCETIRIZINE DIHYDROCHLORIDE

Brand Name : LEVOCETIRIZINE DIHYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Approval Date : 2013-01-31

Application Number : 90362

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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08

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LEVOCETIRIZINE DIHYDROCHLORIDE

Brand Name : LEVOCETIRIZINE DIHYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Approval Date : 2010-11-26

Application Number : 90229

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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09

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LEVOCETIRIZINE DIHYDROCHLORIDE

Brand Name : LEVOCETIRIZINE DIHYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Approval Date : 2011-08-22

Application Number : 90199

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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10

DR REDDYS LABS LTD

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DR REDDYS LABS LTD

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LEVOCETIRIZINE DIHYDROCHLORIDE

Brand Name : LEVOCETIRIZINE DIHYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Approval Date : 2011-02-24

Application Number : 90392

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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