Memantine HCl | FDA Orange Book | Approved Drug Product List

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Peptide Therapy Summit

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

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02

ALLERGAN

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Peptide Therapy Summit

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Dosage Strength : 2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

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Product Web Link

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03

STRIDES PHARMA

India

CPhI WW Frankfurt

Booth # 9.1F6 & 9.1G41

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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Peptide Therapy Summit

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

Portfolio PDF

Product Web Link

Corporate PDF

05

ABBVIE

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Peptide Therapy Summit

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Dosage Strength : 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

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06

ABBVIE

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Peptide Therapy Summit

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 :

Portfolio PDF

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07

ABBVIE

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Peptide Therapy Summit

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 :

Portfolio PDF

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08

ABBVIE

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Peptide Therapy Summit

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 :

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09

ABBVIE

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Peptide Therapy Summit

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

Portfolio PDF

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10

ABBVIE

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Peptide Therapy Summit

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;28MG

Approval Date : 2014-12-23

Application Number : 206439

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Portfolio PDF

Product Web Link