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Approved Drug Products containing NCGC00024890-10 listed in the FDA Orange Book. Original Data : FDA Website

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01 1ACCORD HLTHCARE

02 1ACTAVIS LABS FL INC

03 1ALKEM LABS LTD

04 1AUROBINDO PHARMA

05 1HIKMA

06 1MERZ PHARMS GMBH

07 1MICRO LABS

08 1RISING

09 1SUN PHARM

10 1TEVA PHARMS USA INC

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PharmaCompass

01

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

DALFAMPRIDINE

Brand Name : DALFAMPRIDINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG

Approval Date : 2018-07-11

Application Number : 206863

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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02

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

DALFAMPRIDINE

Brand Name : DALFAMPRIDINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG

Approval Date : 2017-01-23

Application Number : 206836

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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03

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

DALFAMPRIDINE

Brand Name : DALFAMPRIDINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG

Approval Date : 2018-07-30

Application Number : 206765

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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04

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

DALFAMPRIDINE

Brand Name : DALFAMPRIDINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG

Approval Date : 2017-01-23

Application Number : 206811

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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05

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

DALFAMPRIDINE

Brand Name : DALFAMPRIDINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG

Approval Date : 2018-10-24

Application Number : 206646

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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06

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

DALFAMPRIDINE

Brand Name : DALFAMPRIDINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG

Approval Date : 2019-03-11

Application Number : 210158

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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07

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

DALFAMPRIDINE

Brand Name : DALFAMPRIDINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG

Approval Date : 2020-07-06

Application Number : 206858

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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08

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

DALFAMPRIDINE

Brand Name : DALFAMPRIDINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG

Approval Date : 2019-05-21

Application Number : 208292

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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09

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

DALFAMPRIDINE

Brand Name : DALFAMPRIDINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG

Approval Date :

Application Number : 206854

RX/OTC/DISCN :

RLD :

TE Code :

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10

MERZ PHARMS GMBH

Country
BioProcess International
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MERZ PHARMS GMBH

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BioProcess International
Not Confirmed

DALFAMPRIDINE

Brand Name : AMPYRA

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG

Approval Date : 2010-01-22

Application Number : 22250

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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