APPLICATION
ANDA072838
TYPE
ANDA
ORIGINAL APPROVAL
1992-11-05
LATEST ACTION
2020-05-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
DILTIAZEM HYDROCHLORIDEDiscontinued
DILTIAZEM HYDROCHLORIDE 30MG · TABLET · ORAL
DILTIAZEM HYDROCHLORIDEDiscontinued
DILTIAZEM HYDROCHLORIDE 90MG · TABLET · ORAL
DILTIAZEM HYDROCHLORIDEDiscontinued
DILTIAZEM HYDROCHLORIDE 60MG · TABLET · ORAL
DILTIAZEM HYDROCHLORIDEDiscontinued
DILTIAZEM HYDROCHLORIDE 120MG · TABLET · ORAL
Approval history
2020-05-21Labeling · Supplement 24 · standardAP
2020-04-08Labeling · Supplement 23 · standardAP
2011-11-29Labeling · Supplement 19AP
2007-04-12Manufacturing (CMC) · Supplement 11AP
1999-07-12Manufacturing (CMC) · Supplement 7AP
1996-12-12Labeling · Supplement 6AP
1995-08-29Labeling · Supplement 4AP
1995-08-29Manufacturing (CMC) · Supplement 3AP
1995-07-13Labeling · Supplement 5AP
1993-12-13Labeling · 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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