Memantine Hydrochloride | FDA Orange Book | Approved Drug Product List

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BioAsia

Not Confirmed

U.S.A

RLD : Yes

TE Code : AB

Brand Name : NAMENDA

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Approval Date : 2003-10-16

Application Number : 21487

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Product Web Link

Corporate PDF

02

ALLERGAN

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BioAsia

Not Confirmed

U.S.A

RLD : Yes

TE Code :

Brand Name : NAMENDA

Dosage Form : SOLUTION;ORAL

Dosage Strength : 2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2005-04-18

Application Number : 21627

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Website

Corporate PDF

03

STRIDES PHARMA

India

BioAsia

Not Confirmed

Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

India

RLD : No

TE Code : AB

Brand Name : MEMANTINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Approval Date : 2017-05-23

Application Number : 202350

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

04

ABBVIE

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BioAsia

Not Confirmed

U.S.A

RLD : Yes

TE Code : AB

Brand Name : NAMENDA

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2003-10-16

Application Number : 21487

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Product Web Link

Corporate PDF

05

ABBVIE

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BioAsia

Not Confirmed

U.S.A

RLD : Yes

TE Code :

Brand Name : NAMENDA XR

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2010-06-21

Application Number : 22525

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Product Web Link

Corporate PDF

06

ABBVIE

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BioAsia

Not Confirmed

U.S.A

RLD : Yes

TE Code :

Brand Name : NAMENDA XR

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 14MG

Approval Date : 2010-06-21

Application Number : 22525

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Product Web Link

Corporate PDF

07

ABBVIE

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BioAsia

Not Confirmed

U.S.A

RLD : Yes

TE Code :

Brand Name : NAMENDA XR

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 21MG

Approval Date : 2010-06-21

Application Number : 22525

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Product Web Link

Corporate PDF

08

ABBVIE

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BioAsia

Not Confirmed

U.S.A

RLD : Yes

TE Code :

Brand Name : NAMENDA XR

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 28MG

Approval Date : 2010-06-21

Application Number : 22525

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Product Web Link

Corporate PDF

09

ABBVIE

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BioAsia

Not Confirmed

U.S.A

RLD : Yes

TE Code : AB

DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE

Brand Name : NAMZARIC

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG;14MG

Approval Date : 2014-12-23

Application Number : 206439

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Product Web Link

Corporate PDF

10

ABBVIE

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BioAsia

Not Confirmed

U.S.A