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

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01

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CICLOPIROX

Brand Name : CICLOPIROX

Dosage Form : CREAM;TOPICAL

Dosage Strength : 0.77%

Approval Date : 2005-04-12

Application Number : 76790

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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02

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CICLOPIROX

Brand Name : CICLOPIROX

Dosage Form : SUSPENSION;TOPICAL

Dosage Strength : 0.77%

Approval Date : 2005-08-10

Application Number : 77092

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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03

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CICLOPIROX

Brand Name : CICLOPIROX

Dosage Form : SOLUTION;TOPICAL

Dosage Strength : 8%

Approval Date : 2007-09-18

Application Number : 78144

RX/OTC/DISCN : RX

RLD : No

TE Code : AT

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04

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CICLOPIROX

Brand Name : CICLOPIROX

Dosage Form : SHAMPOO;TOPICAL

Dosage Strength : 1%

Approval Date : 2011-02-23

Application Number : 90269

RX/OTC/DISCN : RX

RLD : No

TE Code : AT

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05

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CICLOPIROX

Brand Name : CICLOPIROX

Dosage Form : GEL;TOPICAL

Dosage Strength : 0.77% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1997-07-21

Application Number : 20519

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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06

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CICLOPIROX

Brand Name : LOPROX

Dosage Form : SHAMPOO;TOPICAL

Dosage Strength : 1%

Approval Date : 2003-02-28

Application Number : 21159

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AT

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CICLOPIROX

Brand Name : PENLAC

Dosage Form : SOLUTION;TOPICAL

Dosage Strength : 8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1999-12-17

Application Number : 21022

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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08

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CICLOPIROX

Brand Name : CICLOPIROX

Dosage Form : SUSPENSION;TOPICAL

Dosage Strength : 0.77%

Approval Date : 2004-08-06

Application Number : 76422

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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09

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CICLOPIROX

Brand Name : LOPROX

Dosage Form : CREAM;TOPICAL

Dosage Strength : 0.77%

Approval Date : 1982-12-30

Application Number : 18748

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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CICLOPIROX

Brand Name : LOPROX

Dosage Form : SUSPENSION;TOPICAL

Dosage Strength : 0.77%

Approval Date : 1988-12-30

Application Number : 19824

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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