Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 205171
Company: MYLAN

Products on ANDA 205171

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALMOTRIPTAN MALATE	ALMOTRIPTAN MALATE	EQ 6.25MG BASE	TABLET;ORAL	Prescription	AB	No	No
ALMOTRIPTAN MALATE	ALMOTRIPTAN MALATE	EQ 12.5MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205171

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/09/2015	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
04/15/2025	SUPPL-2	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 205171

ALMOTRIPTAN MALATE

TABLET;ORAL; EQ 6.25MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALMOTRIPTAN MALATE	ALMOTRIPTAN MALATE	EQ 6.25MG BASE	TABLET;ORAL	Prescription	No	AB	205523	AJANTA PHARMA LTD
ALMOTRIPTAN MALATE	ALMOTRIPTAN MALATE	EQ 6.25MG BASE	TABLET;ORAL	Prescription	No	AB	205171	MYLAN
ALMOTRIPTAN MALATE	ALMOTRIPTAN MALATE	EQ 6.25MG BASE	TABLET;ORAL	Prescription	No	AB	078027	TEVA PHARMS USA

TABLET;ORAL; EQ 12.5MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALMOTRIPTAN MALATE	ALMOTRIPTAN MALATE	EQ 12.5MG BASE	TABLET;ORAL	Prescription	No	AB	205523	AJANTA PHARMA LTD
ALMOTRIPTAN MALATE	ALMOTRIPTAN MALATE	EQ 12.5MG BASE	TABLET;ORAL	Prescription	No	AB	205171	MYLAN
ALMOTRIPTAN MALATE	ALMOTRIPTAN MALATE	EQ 12.5MG BASE	TABLET;ORAL	Prescription	No	AB	078027	TEVA PHARMS USA