APPLICATION
ANDA074079
TYPE
ANDA
ORIGINAL APPROVAL
1993-11-30
LATEST ACTION
2002-11-27
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
DILTIAZEM HYDROCHLORIDEDiscontinued
DILTIAZEM HYDROCHLORIDE 90MG · CAPSULE, EXTENDED RELEASE · ORAL
DILTIAZEM HYDROCHLORIDEDiscontinued
DILTIAZEM HYDROCHLORIDE 120MG · CAPSULE, EXTENDED RELEASE · ORAL
DILTIAZEM HYDROCHLORIDEDiscontinued
DILTIAZEM HYDROCHLORIDE 60MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2002-11-27Manufacturing (CMC) · Supplement 8AP
2000-07-07Manufacturing (CMC) · Supplement 7AP
1999-03-22Manufacturing (CMC) · Supplement 6AP
1998-06-12Labeling · Supplement 5AP
1997-05-12Labeling · Supplement 4AP
1995-01-09Manufacturing (CMC) · Supplement 2AP
1994-06-30Manufacturing (CMC) · Supplement 1AP
1993-11-30OriginalAP
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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