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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203269
Company: ALKEM LABS LTD

Products on ANDA 203269

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET;ORAL	Prescription	AB	No	No
RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203269

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/18/2016	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/22/2020	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
01/22/2020	SUPPL-3	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
05/19/2016	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203269

RIZATRIPTAN BENZOATE

TABLET;ORAL; EQ 5MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	203269	ALKEM LABS LTD
RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	202490	AUROBINDO PHARMA LTD
RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	077526	CHARTWELL RX
RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	202047	CREEKWOOD PHARMS
RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	201967	GLENMARK PHARMS LTD
RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	203147	MACLEODS PHARMS LTD
RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	201993	MYLAN PHARMS INC
RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	200482	NATCO PHARMA LTD
RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	077263	TEVA PHARMS

TABLET;ORAL; EQ 10MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MAXALT	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET;ORAL	Prescription	Yes	AB	020864	ORGANON LLC
RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	203269	ALKEM LABS LTD
RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	202490	AUROBINDO PHARMA LTD
RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	077526	CHARTWELL RX
RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	202047	CREEKWOOD PHARMS
RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	201967	GLENMARK PHARMS LTD
RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	203147	MACLEODS PHARMS LTD
RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	201993	MYLAN PHARMS INC
RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	200482	NATCO PHARMA LTD
RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	077263	TEVA PHARMS

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