FDA NDA · NDA020504

HYDROCHLOROTHIAZIDE

Sponsor: TEVA BRANDED PHARM

APPLICATION

NDA020504

TYPE

NDA

ORIGINAL APPROVAL

1996-12-27

LATEST ACTION

2020-08-20

ROUTE

ORAL

DOSAGE FORM

CAPSULE

MARKETING STATUS

Prescription

Products

MICROZIDE · ReferencePrescription

HYDROCHLOROTHIAZIDE 12.5MG · CAPSULE · ORAL

2020-08-20Labeling · Supplement 26 · standard — Label ↗AP

2017-01-26Manufacturing (CMC) · Supplement 24 · standardAP

2015-09-16Manufacturing (CMC) · Supplement 23 · standardAP

2011-03-15Labeling · Supplement 18 · unknown — Letter ↗AP

2002-12-20Manufacturing (CMC) · Supplement 2 · standardAP

2001-05-07Manufacturing (CMC) · Supplement 1 · standardAP

1996-12-27Type 3 - New Dosage Form · 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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