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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022250
Company: MERZ PHARMS

Medication Guide

Other Important Information from FDA

Products on NDA 022250

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMPYRA	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022250

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/22/2010	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022250s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022250s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022250s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/18/2021	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022250s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022250Orig1s019ltr.pdf
02/24/2021	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022250s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022250Orig1s018ltr.pdf
12/19/2019	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/22250s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022250Orig1s017ltr.pdf
09/29/2017	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022250s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022250Orig1s015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022250Orig1s015ltr.pdf
10/13/2016	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022250s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022250Orig1s013ltr.pdf
08/22/2014	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
06/18/2013	SUPPL-8	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022250Orig1s008ltr.pdf
12/21/2012	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022250s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022250Orig1s007ltr.pdf
01/22/2013	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022250s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022250Orig1s006ltr.pdf
07/20/2012	SUPPL-4	Labeling-Medication Guide, REMS-Modified	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022250s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022250Orig1s004ltr.pdf
07/20/2012	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022250s003s004lbl.pdf
11/17/2011	SUPPL-2	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022250s002ltr.pdf
09/30/2014	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 022250

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/18/2021	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022250s019lbl.pdf
02/24/2021	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022250s018lbl.pdf
12/19/2019	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/22250s017lbl.pdf
09/29/2017	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022250s015lbl.pdf
10/13/2016	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022250s013lbl.pdf
01/22/2013	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022250s006lbl.pdf
12/21/2012	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022250s007lbl.pdf
07/20/2012	SUPPL-4	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022250s003s004lbl.pdf
07/20/2012	SUPPL-4	REMS-Modified	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022250s003s004lbl.pdf
07/20/2012	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022250s003s004lbl.pdf
01/22/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022250s000lbl.pdf

Therapeutic Equivalents for NDA 022250

AMPYRA

TABLET, EXTENDED RELEASE;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMPYRA	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	022250	MERZ PHARMS
DALFAMPRIDINE	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	206863	ACCORD HLTHCARE
DALFAMPRIDINE	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	206836	ACTAVIS LABS FL INC
DALFAMPRIDINE	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	206765	ALKEM LABS LTD
DALFAMPRIDINE	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	206811	AUROBINDO PHARMA
DALFAMPRIDINE	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	210158	MICRO LABS
DALFAMPRIDINE	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	208292	SUN PHARM

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