Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205523
Company: AJANTA PHARMA LTD

Products on ANDA 205523

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205523

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/03/2016	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 205523

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