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FDA ANDA · ANDA071782

CLORAZEPATE DIPOTASSIUM

Sponsor: ABLE

APPLICATION
ANDA071782
TYPE
ANDA
ORIGINAL APPROVAL
1987-06-26
LATEST ACTION
2004-12-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

CLORAZEPATE DIPOTASSIUMDiscontinued
CLORAZEPATE DIPOTASSIUM 15MG · TABLET · ORAL

Approval history

2004-12-02Labeling · Supplement 8AP
2001-03-28Manufacturing (CMC) · Supplement 7AP
1994-08-15Labeling · Supplement 6AP
1992-11-25Manufacturing (CMC) · Supplement 5AP
1988-08-22Manufacturing (CMC) · Supplement 4AP
1988-03-10Labeling · Supplement 2AP
1988-03-10Manufacturing (CMC) · Supplement 3AP
1988-03-10Manufacturing (CMC) · Supplement 1AP
1987-06-26OriginalAP
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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