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Approved Drug Products containing Prestwick3_000495 listed in the FDA Orange Book. Original Data : FDA Website

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01 3TARO

02 2FOUGERA PHARMS

03 1FOUGERA PHARMS INC

04 3JANSSEN PHARMS

05 1PADAGIS ISRAEL

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01

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TERCONAZOLE

Brand Name : TERCONAZOLE

Dosage Form : CREAM;VAGINAL

Dosage Strength : 0.8%

Approval Date : 2004-04-06

Application Number : 75953

RX/OTC/DISCN : RX

RLD : No

TE Code : BX

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02

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TERCONAZOLE

Brand Name : TERCONAZOLE

Dosage Form : CREAM;VAGINAL

Dosage Strength : 0.4%

Approval Date : 2005-01-19

Application Number : 76043

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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03

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TERCONAZOLE

Brand Name : TERCONAZOLE

Dosage Form : SUPPOSITORY;VAGINAL

Dosage Strength : 80MG

Approval Date : 2007-03-09

Application Number : 77553

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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04

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TERCONAZOLE

Brand Name : TERCONAZOLE

Dosage Form : CREAM;VAGINAL

Dosage Strength : 0.8%

Approval Date : 2004-10-01

Application Number : 21735

RX/OTC/DISCN : RX

RLD : Yes

TE Code : BX

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05

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TERCONAZOLE

Brand Name : TERCONAZOLE

Dosage Form : CREAM;VAGINAL

Dosage Strength : 0.4%

Approval Date : 2005-02-18

Application Number : 76712

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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06

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TERCONAZOLE

Brand Name : TERCONAZOLE

Dosage Form : SUPPOSITORY;VAGINAL

Dosage Strength : 80MG

Approval Date : 2006-07-12

Application Number : 76850

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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07

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TERCONAZOLE

Brand Name : TERAZOL 7

Dosage Form : CREAM;VAGINAL

Dosage Strength : 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1987-12-31

Application Number : 19579

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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08

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TERCONAZOLE

Brand Name : TERAZOL 3

Dosage Form : SUPPOSITORY;VAGINAL

Dosage Strength : 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1988-05-24

Application Number : 19641

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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09

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TERCONAZOLE

Brand Name : TERAZOL 3

Dosage Form : CREAM;VAGINAL

Dosage Strength : 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1991-02-21

Application Number : 19964

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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10

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TERCONAZOLE

Brand Name : TERCONAZOLE

Dosage Form : SUPPOSITORY;VAGINAL

Dosage Strength : 80MG

Approval Date : 2006-03-17

Application Number : 77149

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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