APPLICATION
ANDA075124
TYPE
ANDA
ORIGINAL APPROVAL
1998-03-18
LATEST ACTION
2011-09-20
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
DILTIAZEM HYDROCHLORIDEDiscontinued
DILTIAZEM HYDROCHLORIDE 120MG · CAPSULE, EXTENDED RELEASE · ORAL
DILTIAZEM HYDROCHLORIDEDiscontinued
DILTIAZEM HYDROCHLORIDE 180MG · CAPSULE, EXTENDED RELEASE · ORAL
DILTIAZEM HYDROCHLORIDEDiscontinued
DILTIAZEM HYDROCHLORIDE 240MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2011-09-20Labeling · Supplement 18AP
2011-01-27Labeling · Supplement 16AP
2005-01-27Labeling · Supplement 9AP
2004-03-24Labeling · Supplement 8AP
2002-08-07Manufacturing (CMC) · Supplement 3AP
2000-11-07Labeling · Supplement 2AP
1999-02-05Manufacturing (CMC) · Supplement 1AP
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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