Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206765
Company: ALKEM LABS LTD

Products on ANDA 206765

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 206765

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/30/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/21/2025	SUPPL-16	Labeling, Labeling-Package Insert		Label is not available on this site.
05/01/2023	SUPPL-11	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/15/2021	SUPPL-7	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/15/2021	SUPPL-6	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 206765

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