Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203146
Company: MACLEODS PHARMS LTD

Products on ANDA 203146

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203146

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/19/2014	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203146Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/07/2023	SUPPL-22	Labeling-Patient Package Insert, Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
11/29/2019	SUPPL-17	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203146

RIZATRIPTAN BENZOATE

TABLET, ORALLY DISINTEGRATING;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, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	203062	AUROBINDO PHARMA LTD
RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	203146	MACLEODS PHARMS LTD
RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	204722	PANACEA

TABLET, ORALLY DISINTEGRATING;ORAL; EQ 10MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MAXALT-MLT	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	Yes	AB	020865	ORGANON
RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	203062	AUROBINDO PHARMA LTD
RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	203146	MACLEODS PHARMS LTD
RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	204722	PANACEA