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Approved Drug Products containing DSSTox_CID_3224 listed in the FDA Orange Book. Original Data : FDA Website

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01 3TARO

02 1STRIDES PHARMA

03 1GRANULES

04 1ACTAVIS LABS FL INC

05 1APOTEX INC

06 1AUROBINDO PHARMA

07 3AUROBINDO PHARMA LTD

08 12BAYER HEALTHCARE LLC

09 2BIONPHARMA

10 1FDN CONSUMER

11 1GLAXOSMITHKLINE

12 1GUARDIAN DRUG

13 1HERITAGE PHARMA

14 1HETERO LABS LTD III

15 1HETERO LABS LTD V

16 1LANNETT CO INC

17 1MARKSANS PHARMA

18 1MYLAN

19 2NORVIUM BIOSCIENCE

20 1P AND L

21 3PERRIGO

22 4PERRIGO PHARMA INTL

23 2PHARM ASSOC

24 1PLD ACQUISITIONS LLC

25 1RANBAXY LABS LTD

26 1RUBICON

27 1SUN PHARM

28 3SUN PHARM INDS LTD

29 2TENSHI

30 1TEVA

31 1UNIQUE PHARM

32 1WOCKHARDT BIO AG

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

RLD : No

TE Code :

LORATADINE

Brand Name : LORATADINE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 10MG

Approval Date : 2020-01-15

Application Number : 211926

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Strides Pharma Science

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 :

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

03

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BioProcess International
Not Confirmed

LORATADINE

Brand Name : LORATADINE

Dosage Form : SUSPENSION;ORAL

Dosage Strength : 1MG/ML

Approval Date : 2005-10-04

Application Number : 21734

RX/OTC/DISCN : OTC

RLD : Yes

TE Code :

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04

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BioProcess International
Not Confirmed

LORATADINE

Brand Name : LORATADINE

Dosage Form : SYRUP;ORAL

Dosage Strength : 1MG/ML

Approval Date : 2004-08-20

Application Number : 76805

RX/OTC/DISCN : OTC

RLD : No

TE Code :

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05

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BioProcess International
Not Confirmed

LORATADINE

Brand Name : LORATADINE

Dosage Form : SYRUP;ORAL

Dosage Strength : 1MG/ML

Approval Date : 2015-07-31

Application Number : 201865

RX/OTC/DISCN : OTC

RLD : No

TE Code :

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06

BioProcess International
Not Confirmed
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BioProcess International
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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07

BioProcess International
Not Confirmed
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BioProcess International
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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08

BioProcess International
Not Confirmed
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BioProcess International
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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09

BioProcess International
Not Confirmed
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BioProcess International
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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10

BioProcess International
Not Confirmed
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BioProcess International
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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