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FDA ANDA · ANDA087296

CHLORTHALIDONE

Sponsor: ANI PHARMS

APPLICATION
ANDA087296
TYPE
ANDA
ORIGINAL APPROVAL
1981-08-19
LATEST ACTION
1994-09-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

CHLORTHALIDONEDiscontinued
CHLORTHALIDONE 25MG · TABLET · ORAL

Approval history

1994-09-14Manufacturing (CMC) · Supplement 19AP
1994-03-04Labeling · Supplement 17AP
1991-05-31Manufacturing (CMC) · Supplement 15AP
1990-06-29Manufacturing (CMC) · Supplement 14AP
1988-03-29Manufacturing (CMC) · Supplement 12AP
1988-03-29Manufacturing (CMC) · Supplement 11AP
1988-02-11Manufacturing (CMC) · Supplement 13AP
1985-08-29Manufacturing (CMC) · Supplement 7AP
1985-08-29Manufacturing (CMC) · Supplement 8AP
1985-03-11Manufacturing (CMC) · Supplement 6AP
1984-05-15Manufacturing (CMC) · Supplement 5AP
1984-01-30Manufacturing (CMC) · Supplement 2AP
1983-02-25Manufacturing (CMC) · Supplement 1AP
1981-08-19OriginalAP
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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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