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

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01 1ACTAVIS MID ATLANTIC

02 2ANI PHARMS

03 1APOTEX INC

04 1GENUS

05 1HALEON US HOLDINGS

06 1L PERRIGO CO

07 1NEW HEIGHTSRX

08 5NOVARTIS

09 1OMNIVIUM PHARMS

10 1PLD ACQUISITIONS LLC

11 1TEVA

12 1TEVA PHARMS

13 1WOCKHARDT BIO AG

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PharmaCompass

01

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

CLEMASTINE FUMARATE

Brand Name : CLEMASTINE FUMARATE

Dosage Form : TABLET;ORAL

Dosage Strength : 1.34MG

Approval Date : 1992-01-31

Application Number : 73282

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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02

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

CLEMASTINE FUMARATE

Brand Name : CLEMASTINE FUMARATE

Dosage Form : TABLET;ORAL

Dosage Strength : 1.34MG

Approval Date : 1992-12-03

Application Number : 73282

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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03

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

CLEMASTINE FUMARATE

Brand Name : TAVIST-1

Dosage Form : TABLET;ORAL

Dosage Strength : 1.34MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1992-08-21

Application Number : 20925

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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04

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

CLEMASTINE FUMARATE

Brand Name : TAVIST

Dosage Form : TABLET;ORAL

Dosage Strength : 2.68MG

Approval Date : 1982-01-01

Application Number : 17661

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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05

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

CLEMASTINE FUMARATE

Brand Name : TAVIST-1

Dosage Form : TABLET;ORAL

Dosage Strength : 1.34MG

Approval Date : 1982-01-01

Application Number : 17661

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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06

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

CLEMASTINE FUMARATE

Brand Name : TAVIST-1

Dosage Form : TABLET;ORAL

Dosage Strength : 1.34MG

Approval Date : 1992-08-21

Application Number : 17661

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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07

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

CLEMASTINE FUMARATE

Brand Name : TAVIST

Dosage Form : SYRUP;ORAL

Dosage Strength : EQ 0.5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1985-06-28

Application Number : 18675

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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08

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

ACETAMINOPHEN; CLEMASTINE FUMARATE; PSEUDOEPHEDRINE HYDROCHLORIDE

Brand Name : TAVIST ALLERGY/SINUS/HEADACHE

Dosage Form : TABLET;ORAL

Dosage Strength : 500MG;EQ 0.25MG BASE;30MG

Approval Date : 2001-03-01

Application Number : 21082

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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09

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

CLEMASTINE FUMARATE

Brand Name : CLEMASTINE FUMARATE

Dosage Form : SYRUP;ORAL

Dosage Strength : EQ 0.5MG BASE/5ML

Approval Date : 1992-04-21

Application Number : 73095

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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10

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

CLEMASTINE FUMARATE

Brand Name : CLEMASTINE FUMARATE

Dosage Form : TABLET;ORAL

Dosage Strength : 2.68MG

Approval Date : 1992-01-31

Application Number : 73283

RX/OTC/DISCN : RX

RLD : No

TE Code :

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