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FDA ANDA · ANDA088164

CHLORTHALIDONE

Sponsor: ANI PHARMS

APPLICATION
ANDA088164
TYPE
ANDA
ORIGINAL APPROVAL
1984-01-09
LATEST ACTION
2002-07-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

CHLORTHALIDONEDiscontinued
CHLORTHALIDONE 25MG · TABLET · ORAL

Approval history

2002-07-29Manufacturing (CMC) · Supplement 14AP
2000-01-28Manufacturing (CMC) · Supplement 13AP
1996-04-02Manufacturing (CMC) · Supplement 11AP
1996-04-02Manufacturing (CMC) · Supplement 12AP
1996-04-02Manufacturing (CMC) · Supplement 10AP
1995-01-27Labeling · Supplement 9AP
1993-03-08Labeling · Supplement 8AP
1985-10-24Manufacturing (CMC) · Supplement 1AP
1984-09-17Manufacturing (CMC) · Supplement 5AP
1984-04-23Manufacturing (CMC) · Supplement 2AP
1984-04-23Manufacturing (CMC) · Supplement 3AP
1984-01-09OriginalAP
VIEW ON DRUGS@FDA ↗

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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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