Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017681
Company: US PHARM HOLDINGS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HIPREX METHENAMINE HIPPURATE 1GM TABLET;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/09/1976 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
12/01/2017 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017681s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017681Orig1s018ltr.pdf
08/01/2016 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

11/21/2005 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/17681s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/17681s014ltr.pdf
06/10/2004 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17681slr013_hiprex_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17681slr013ltr.pdf
08/09/1988 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/28/1988 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/03/1989 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

05/03/1984 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/25/1984 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/26/1982 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

03/19/1981 SUPPL-5 Labeling

Label is not available on this site.

11/25/1980 SUPPL-4 Labeling

Label is not available on this site.

11/25/1980 SUPPL-3 Labeling

Label is not available on this site.

02/27/1978 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/24/1978 SUPPL-1 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
12/01/2017 SUPPL-18 Labeling-Package Insert Label (PDF) Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017681s018lbl.pdf
11/21/2005 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/17681s014lbl.pdf
06/10/2004 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17681slr013_hiprex_lbl.pdf

HIPREX

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 US PHARM HOLDINGS
METHENAMINE HIPPURATE METHENAMINE HIPPURATE 1GM TABLET;ORAL Prescription No AB 205661 AUROBINDO PHARMA LTD
METHENAMINE HIPPURATE METHENAMINE HIPPURATE 1GM TABLET;ORAL Prescription No AB 076411 IMPAX LABS INC
METHENAMINE HIPPURATE METHENAMINE HIPPURATE 1GM TABLET;ORAL Prescription No AB 212172 MICRO LABS
UREX METHENAMINE HIPPURATE 1GM TABLET;ORAL Prescription No AB 016151 CNTY LINE PHARMS

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