APPLICATION
ANDA074852
TYPE
ANDA
ORIGINAL APPROVAL
1997-10-10
LATEST ACTION
2007-08-30
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
DILTIAZEM HYDROCHLORIDEDiscontinued
DILTIAZEM HYDROCHLORIDE 180MG · CAPSULE, EXTENDED RELEASE · ORAL
DILTIAZEM HYDROCHLORIDEDiscontinued
DILTIAZEM HYDROCHLORIDE 240MG · CAPSULE, EXTENDED RELEASE · ORAL
DILTIAZEM HYDROCHLORIDEDiscontinued
DILTIAZEM HYDROCHLORIDE 120MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2007-08-30Labeling · Supplement 14AP
2007-03-12Labeling · Supplement 13AP
2002-12-24Manufacturing (CMC) · Supplement 7AP
2002-10-11Manufacturing (CMC) · Supplement 6AP
2001-02-15Manufacturing (CMC) · Supplement 5AP
2000-08-16Manufacturing (CMC) · Supplement 4AP
2000-05-16Manufacturing (CMC) · Supplement 3AP
1999-04-07Manufacturing (CMC) · Supplement 1AP
1999-04-07Manufacturing (CMC) · Supplement 2AP
1997-10-10OriginalAP
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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