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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016151
Company: ALVOGEN

Products on NDA 016151

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 016151

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/05/1967	ORIG-1	Approval	Type 2 - New Active Ingredient	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
03/30/2015	SUPPL-28	Manufacturing (CMC)		Label is not available on this site.
03/11/2008	SUPPL-25	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016151s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016151s025ltr.pdf
07/02/1993	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
08/10/1988	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
11/10/1992	SUPPL-20	Labeling		Label is not available on this site.
04/21/1986	SUPPL-19	Labeling		Label is not available on this site.
03/06/1989	SUPPL-18	Labeling		Label is not available on this site.
07/24/1975	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 016151

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/11/2008	SUPPL-25	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016151s025lbl.pdf

Therapeutic Equivalents for NDA 016151

UREX

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	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	210068	NOVAST LABS
METHENAMINE HIPPURATE	METHENAMINE HIPPURATE	1GM	TABLET;ORAL	Prescription	No	AB	219661	ZYDUS LIFESCIENCES
UREX	METHENAMINE HIPPURATE	1GM	TABLET;ORAL	Prescription	No	AB	016151	ALVOGEN

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