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01 1GRANULES

02 1ACTAVIS LABS FL INC

03 1ANDA REPOSITORY

04 1APOTEX

05 1AUROBINDO PHARMA

06 3AUROBINDO PHARMA LTD

07 12BAYER HEALTHCARE LLC

08 2BIONPHARMA

09 1CATALENT PHARMA

10 1FDN CONSUMER

11 1GLAXOSMITHKLINE

12 1HERITAGE PHARMA

13 1HETERO LABS LTD III

14 1HETERO LABS LTD V

15 1LANNETT CO INC

16 2MARKSANS PHARMA

17 1MYLAN

18 1ONESOURCE SPECIALTY

19 1P AND L

20 3PERRIGO

21 4PERRIGO PHARMA INTL

22 2PHARM ASSOC

23 2PHARMOBEDIENT

24 1PLD ACQUISITIONS LLC

25 1RANBAXY LABS LTD

26 1RUBICON RESEARCH

27 2SUN PHARM

28 3SUN PHARM INDS LTD

29 1SUN PHARMA CANADA

30 2TARO

31 2TENSHI

32 1TEVA

33 1UNIQUE PHARM

34 1WOCKHARDT BIO AG

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PharmaCompass

01

  • 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 :

LORATADINE

Brand Name : LORATADINE

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2019-12-23

Application Number : 210722

RX/OTC/DISCN : OTC

RLD : No

TE Code :

Granules India

02

Peptide Process CMC
Not Confirmed
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Peptide Process CMC
Not Confirmed

LORATADINE

Brand Name : CLARITIN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2002-11-27

Application Number : 19658

RX/OTC/DISCN : OTC

RLD : Yes

TE Code :

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03

Peptide Process CMC
Not Confirmed
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Peptide Process CMC
Not Confirmed

LORATADINE

Brand Name : CLARITIN HIVES RELIEF

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2003-11-19

Application Number : 19658

RX/OTC/DISCN : OTC

RLD : Yes

TE Code :

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04

Peptide Process CMC
Not Confirmed
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Peptide Process CMC
Not Confirmed

LORATADINE; PSEUDOEPHEDRINE SULFATE

Brand Name : CLARITIN-D

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 5MG;120MG

Approval Date : 2002-11-27

Application Number : 19670

RX/OTC/DISCN : OTC

RLD : Yes

TE Code :

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05

Peptide Process CMC
Not Confirmed
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Peptide Process CMC
Not Confirmed

LORATADINE; PSEUDOEPHEDRINE SULFATE

Brand Name : CLARITIN-D 24 HOUR

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG;240MG

Approval Date : 2002-11-27

Application Number : 20470

RX/OTC/DISCN : OTC

RLD : Yes

TE Code :

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06

Peptide Process CMC
Not Confirmed
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Peptide Process CMC
Not Confirmed

LORATADINE

Brand Name : CLARITIN

Dosage Form : SYRUP;ORAL

Dosage Strength : 1MG/ML

Approval Date : 2002-11-27

Application Number : 20641

RX/OTC/DISCN : OTC

RLD : Yes

TE Code :

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07

Peptide Process CMC
Not Confirmed
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Peptide Process CMC
Not Confirmed

LORATADINE

Brand Name : CLARITIN HIVES RELIEF

Dosage Form : SYRUP;ORAL

Dosage Strength : 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2003-11-19

Application Number : 20641

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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08

Peptide Process CMC
Not Confirmed
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Peptide Process CMC
Not Confirmed

LORATADINE

Brand Name : CLARITIN REDITABS

Dosage Form : TABLET, ORALLY DISINTEGRATING;ORAL

Dosage Strength : 10MG

Approval Date : 2002-11-27

Application Number : 20704

RX/OTC/DISCN : OTC

RLD : Yes

TE Code :

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09

Peptide Process CMC
Not Confirmed
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Peptide Process CMC
Not Confirmed

LORATADINE

Brand Name : CLARITIN HIVES RELIEF REDITAB

Dosage Form : TABLET, ORALLY DISINTEGRATING;ORAL

Dosage Strength : 10MG

Approval Date : 2003-11-19

Application Number : 20704

RX/OTC/DISCN : OTC

RLD : Yes

TE Code :

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10

Peptide Process CMC
Not Confirmed
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Peptide Process CMC
Not Confirmed

LORATADINE

Brand Name : ALAVERT

Dosage Form : TABLET, ORALLY DISINTEGRATING;ORAL

Dosage Strength : 10MG

Approval Date : 2002-12-19

Application Number : 21375

RX/OTC/DISCN : OTC

RLD : No

TE Code :

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