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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077263
Company: TEVA PHARMS

Products on ANDA 077263

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 077263

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/31/2012	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
02/02/2020	SUPPL-5	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
11/06/2015	SUPPL-1	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 077263

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	203147	MACLEODS PHARMS 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	203147	MACLEODS PHARMS LTD
RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	077263	TEVA PHARMS

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