← FDA DRUG APPROVALS

FDA ANDA · ANDA072510

METHYLDOPA AND HYDROCHLOROTHIAZIDE

Sponsor: DAVA PHARMS INC

APPLICATION
ANDA072510
TYPE
ANDA
ORIGINAL APPROVAL
1989-06-02
LATEST ACTION
1992-04-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

METHYLDOPA AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 50MG, METHYLDOPA 500MG · TABLET · ORAL

Approval history

1992-04-02Labeling · Supplement 1AP
1989-06-02OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

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

Get the Weekly GxP Briefing

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

Read a past issue →