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

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01 2BAUSCH AND LOMB

02 1EXELA PHARMA

03 2RANBAXY LABS LTD

04 2ROCHE PALO

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PharmaCompass

01

Luxepack
Not Confirmed
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GANCICLOVIR

Brand Name : VITRASERT

Dosage Form : IMPLANT;IMPLANTATION

Dosage Strength : 4.5MG

Approval Date : 1996-03-04

Application Number : 20569

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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02

Luxepack
Not Confirmed
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Luxepack
Not Confirmed

GANCICLOVIR

Brand Name : ZIRGAN

Dosage Form : GEL;OPHTHALMIC

Dosage Strength : 0.15%

Approval Date : 2009-09-15

Application Number : 22211

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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03

Luxepack
Not Confirmed
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Luxepack
Not Confirmed

GANCICLOVIR

Brand Name : GANZYK-RTU

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 500MG/250ML (2MG/ML)

Approval Date : 2017-02-17

Application Number : 209347

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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04

Luxepack
Not Confirmed
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Luxepack
Not Confirmed

GANCICLOVIR

Brand Name : CYTOVENE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1994-12-22

Application Number : 20460

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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05

Luxepack
Not Confirmed
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Luxepack
Not Confirmed

GANCICLOVIR

Brand Name : CYTOVENE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1997-12-12

Application Number : 20460

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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06

Luxepack
Not Confirmed
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Luxepack
Not Confirmed

GANCICLOVIR

Brand Name : GANCICLOVIR

Dosage Form : CAPSULE;ORAL

Dosage Strength : 250MG

Approval Date : 2003-06-27

Application Number : 76457

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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07

Luxepack
Not Confirmed
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Luxepack
Not Confirmed

GANCICLOVIR

Brand Name : GANCICLOVIR

Dosage Form : CAPSULE;ORAL

Dosage Strength : 500MG

Approval Date : 2003-06-27

Application Number : 76457

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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