FDA NDA · NDA016151

METHENAMINE HIPPURATE

Sponsor: QUAGEN

APPLICATION

NDA016151

TYPE

NDA

ORIGINAL APPROVAL

1967-07-05

LATEST ACTION

2015-03-30

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Prescription

Products

UREXPrescription

METHENAMINE HIPPURATE 1GM · TABLET · ORAL

2015-03-30Manufacturing (CMC) · Supplement 28 · standardAP

2008-03-11Labeling · Supplement 25 · standard — Letter ↗AP

1993-07-02Manufacturing (CMC) · Supplement 23 · standardAP

1992-11-10Labeling · Supplement 20AP

1989-03-06Labeling · Supplement 18AP

1988-08-10Manufacturing (CMC) · Supplement 21 · standardAP

1986-04-21Labeling · Supplement 19AP

1975-07-24Manufacturing (CMC) · Supplement 15 · standardAP

1967-07-05Type 2 - New Active Ingredient · Original · standardAP

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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