01 1Taro Pharmaceutical Industries
02 1Accord healthcare
03 1Acino Pharma (Pty) Ltd
04 1Actavis Inc
05 1Alkem Laboratories
06 1Ascent Innovative Medicines
07 1Aurobindo Pharma Limited
08 7Biogen
09 4CHEMO
10 1CinnaGen Co
11 1Hikma Pharmaceuticals
12 1Intas Pharmaceuticals
13 1Merz Pharma
14 1Micro Labs Limited
15 1Neuraxpharm
16 2ORIFARM GROUP AS
17 1Pharmascience Inc.
18 1Rising Pharmaceuticals Inc
19 1Sun Pharmaceutical Industries Limited
20 1Teva Pharmaceutical Industries
01 6Depottablett
02 1ER Tablet
03 1Extended Release Tablet
04 4Film Coated Tablet
05 1PROLONGED-RELEASE TABLET
06 1Ret Tablet
07 1SR Tablet
08 1TAB
09 3TABLET (EXTENDED-RELEASE)
10 10TABLET, EXTENDED RELEASE;ORAL
11 1Tablet ER.
01 2DISCN
02 1Originator
03 3Prescription
04 7RX
05 17Blank
01 1AMPYRA
02 9DALFAMPRIDINE
03 1Dalfyra
04 1FAMPYRA
05 9Fampyra
06 1PMS-FAMPRIDINE
07 1TARO-FAMPRIDINE
08 7Blank
01 3Canada
02 2India
03 1Iran
04 6Norway
05 1South Africa
06 5Spain
07 1Sweden
08 1Switzerland
09 10USA
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : TARO-FAMPRIDINE
Dosage Form : TABLET (EXTENDED-RELEASE)
Dosage Strength : 10MG
Packaging : (2X14)/(4X14)/28/56
Approval Date :
Application Number : 2482398
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : RX
Registration Country : USA
Brand Name : DALFAMPRIDINE
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2018-07-11
Application Number : 206863
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DALFAMPRIDINE
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2017-01-23
Application Number : 206836
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DALFAMPRIDINE
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2018-07-30
Application Number : 206765
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DALFAMPRIDINE
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2017-01-23
Application Number : 206811
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Sweden
Brand Name : Fampyra
Dosage Form : PROLONGED-RELEASE TABLET
Dosage Strength : 10 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Norway
Brand Name : Fampyra
Dosage Form : Depottablett
Dosage Strength : 10 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Fampyra
Dosage Form : Depottablett
Dosage Strength : 10 mg
Packaging : Bottle
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Fampyra
Dosage Form : Depottablett
Dosage Strength : 10 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Fampyra
Dosage Form : Depottablett
Dosage Strength : 10 mg
Packaging : Bottle
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Spain
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Regulatory Info :
Registration Country : Iran
Brand Name : Dalfyra
Dosage Form : Tablet ER.
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran
Regulatory Info : DISCN
Registration Country : USA
Brand Name : DALFAMPRIDINE
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2018-10-24
Application Number : 206646
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : AMPYRA
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2010-01-22
Application Number : 22250
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DALFAMPRIDINE
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2019-03-11
Application Number : 210158
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Norway
Brand Name : Fampyra
Dosage Form : Depottablett
Dosage Strength : 10 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Fampyra
Dosage Form : Depottablett
Dosage Strength : 10 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info : DISCN
Registration Country : USA
Brand Name : DALFAMPRIDINE
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2020-07-06
Application Number : 206858
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DALFAMPRIDINE
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2019-05-21
Application Number : 208292
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : DALFAMPRIDINE
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number : 206854
Regulatory Info :
Registration Country : USA
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