Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016151
Company: ALVOGEN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
UREX METHENAMINE HIPPURATE 1GM TABLET;ORAL Prescription AB No No
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.

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

UREX

TABLET;ORAL; 1GM
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METHENAMINE HIPPURATE METHENAMINE HIPPURATE 1GM TABLET;ORAL Prescription No AB 205661 AUROBINDO PHARMA LTD
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
UREX METHENAMINE HIPPURATE 1GM TABLET;ORAL Prescription No AB 016151 ALVOGEN

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