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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210158
Company: MICRO LABS

Products on ANDA 210158

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DALFAMPRIDINE	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210158

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/11/2019	ORIG-1	Approval		STANDARD	Letter (PDF) Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210158Orig1s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210158Orig1s000TAltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/11/2023	SUPPL-5	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/15/2021	SUPPL-4	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/14/2020	SUPPL-3	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 210158

DALFAMPRIDINE

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
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

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