FDA NDA · NDA017364

AQUATENSEN

Sponsor: MEDPOINTE PHARM HLC

APPLICATION

NDA017364

TYPE

NDA

ORIGINAL APPROVAL

1977-09-07

LATEST ACTION

1992-06-12

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Discontinued

Products

AQUATENSENDiscontinued

METHYCLOTHIAZIDE 5MG · TABLET · ORAL

1992-06-12Manufacturing (CMC) · Supplement 11 · standardAP

1992-03-20Labeling · Supplement 10AP

1990-12-03Manufacturing (CMC) · Supplement 9 · standardAP

1988-06-22Labeling · Supplement 8AP

1987-09-29Labeling · Supplement 4AP

1985-01-24Manufacturing (CMC) · Supplement 7 · standardAP

1983-04-28Manufacturing (CMC) · Supplement 5 · standardAP

1981-10-15Manufacturing (CMC) · Supplement 3 · standardAP

1980-01-16Labeling · Supplement 1AP

1979-11-26Manufacturing (CMC) · Supplement 2 · standardAP

1977-09-07Type 5 - New Formulation or New Manufacturer · 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.

Weekly Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.