Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205661
Company: AUROBINDO PHARMA LTD

Products on ANDA 205661

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METHENAMINE HIPPURATE	METHENAMINE HIPPURATE	1GM	TABLET;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205661

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/05/2016	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
05/15/2023	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
05/15/2023	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 205661

METHENAMINE HIPPURATE

TABLET;ORAL; 1GM
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HIPREX	METHENAMINE HIPPURATE	1GM	TABLET;ORAL	Prescription	Yes	AB	017681	ESJAY PHARMA
METHENAMINE HIPPURATE	METHENAMINE HIPPURATE	1GM	TABLET;ORAL	Prescription	No	AB	205661	AUROBINDO PHARMA LTD
METHENAMINE HIPPURATE	METHENAMINE HIPPURATE	1GM	TABLET;ORAL	Prescription	No	AB	210068	INGENUS PHARMS LLC
METHENAMINE HIPPURATE	METHENAMINE HIPPURATE	1GM	TABLET;ORAL	Prescription	No	AB	217675	JUBILANT CADISTA
METHENAMINE HIPPURATE	METHENAMINE HIPPURATE	1GM	TABLET;ORAL	Prescription	No	AB	212172	MICRO LABS
METHENAMINE HIPPURATE	METHENAMINE HIPPURATE	1GM	TABLET;ORAL	Prescription	No	AB	219661	ZYDUS LIFESCIENCES
UREX	METHENAMINE HIPPURATE	1GM	TABLET;ORAL	Prescription	No	AB	016151	QUAGEN