APPLICATION
ANDA074093
TYPE
ANDA
ORIGINAL APPROVAL
1992-11-05
LATEST ACTION
1999-10-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
DILTIAZEM HYDROCHLORIDEDiscontinued
DILTIAZEM HYDROCHLORIDE 120MG · TABLET · ORAL
DILTIAZEM HYDROCHLORIDEDiscontinued
DILTIAZEM HYDROCHLORIDE 60MG · TABLET · ORAL
DILTIAZEM HYDROCHLORIDEDiscontinued
DILTIAZEM HYDROCHLORIDE 90MG · TABLET · ORAL
DILTIAZEM HYDROCHLORIDEDiscontinued
DILTIAZEM HYDROCHLORIDE 30MG · TABLET · ORAL
Approval history
1999-10-04Manufacturing (CMC) · Supplement 14AP
1998-01-29Manufacturing (CMC) · Supplement 13AP
1997-01-28Labeling · Supplement 12AP
1997-01-16Labeling · Supplement 11AP
1996-12-11Manufacturing (CMC) · Supplement 10AP
1996-04-29Manufacturing (CMC) · Supplement 9AP
1995-11-15Labeling · Supplement 8AP
1995-11-07Manufacturing (CMC) · Supplement 6AP
1995-11-07Manufacturing (CMC) · Supplement 7AP
1995-02-08Manufacturing (CMC) · Supplement 5AP
1994-11-23Manufacturing (CMC) · Supplement 4AP
1994-11-23Manufacturing (CMC) · Supplement 3AP
1994-05-10Labeling · Supplement 1AP
1994-04-28Manufacturing (CMC) · Supplement 2AP
1992-11-05OriginalAP
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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