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

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PharmaCompass

01

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GALANTAMINE HYDROBROMIDE

Brand Name : GALANTAMINE HYDROBROMIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 4MG BASE

Approval Date : 2009-09-15

Application Number : 77585

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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02

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GALANTAMINE HYDROBROMIDE

Brand Name : GALANTAMINE HYDROBROMIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 8MG BASE

Approval Date : 2009-09-15

Application Number : 77585

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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03

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GALANTAMINE HYDROBROMIDE

Brand Name : GALANTAMINE HYDROBROMIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 12MG BASE

Approval Date : 2009-09-15

Application Number : 77585

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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04

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GALANTAMINE HYDROBROMIDE

Brand Name : RAZADYNE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2001-02-28

Application Number : 21169

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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05

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GALANTAMINE HYDROBROMIDE

Brand Name : RAZADYNE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2001-02-28

Application Number : 21169

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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06

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GALANTAMINE HYDROBROMIDE

Brand Name : RAZADYNE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2001-02-28

Application Number : 21169

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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07

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GALANTAMINE HYDROBROMIDE

Brand Name : RAZADYNE

Dosage Form : SOLUTION;ORAL

Dosage Strength : 4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2001-06-22

Application Number : 21224

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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08

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GALANTAMINE HYDROBROMIDE

Brand Name : RAZADYNE ER

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

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

Approval Date : 2005-04-01

Application Number : 21615

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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09

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GALANTAMINE HYDROBROMIDE

Brand Name : RAZADYNE ER

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : EQ 16MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2005-04-01

Application Number : 21615

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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10

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GALANTAMINE HYDROBROMIDE

Brand Name : RAZADYNE ER

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2005-04-01

Application Number : 21615

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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