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FDA NDA · NDA017681

METHENAMINE HIPPURATE

Sponsor: ESJAY PHARMA

APPLICATION
NDA017681
TYPE
NDA
ORIGINAL APPROVAL
1976-09-09
LATEST ACTION
2021-12-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

HIPREX · ReferencePrescription
METHENAMINE HIPPURATE 1GM · TABLET · ORAL

Approval history

2021-12-28Manufacturing (CMC) · Supplement 19 — Letter ↗AP
2017-12-01Labeling · Supplement 18 · standard — Letter ↗AP
2016-08-01Manufacturing (CMC) · Supplement 15 · standardAP
2005-11-21Labeling · Supplement 14 · standard — Letter ↗AP
2004-06-10Labeling · Supplement 13 · standard — Letter ↗AP
1989-01-03Manufacturing (CMC) · Supplement 9 · standardAP
1988-08-09Manufacturing (CMC) · Supplement 11 · standardAP
1988-04-28Manufacturing (CMC) · Supplement 10 · standardAP
1984-05-03Manufacturing (CMC) · Supplement 8 · standardAP
1984-04-25Manufacturing (CMC) · Supplement 7 · standardAP
1982-05-26Manufacturing (CMC) · Supplement 6 · standardAP
1981-03-19Labeling · Supplement 5AP
1980-11-25Labeling · Supplement 4AP
1980-11-25Labeling · Supplement 3AP
1978-02-27Manufacturing (CMC) · Supplement 2 · standardAP
1978-02-24Manufacturing (CMC) · Supplement 1 · standardAP
1976-09-09Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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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