APPLICATION
ANDA074943
TYPE
ANDA
ORIGINAL APPROVAL
1998-08-06
LATEST ACTION
2015-08-25
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
DILTIAZEM HYDROCHLORIDEPrescription
DILTIAZEM HYDROCHLORIDE 120MG · CAPSULE, EXTENDED RELEASE · ORAL
DILTIAZEM HYDROCHLORIDEPrescription
DILTIAZEM HYDROCHLORIDE 240MG · CAPSULE, EXTENDED RELEASE · ORAL
DILTIAZEM HYDROCHLORIDEPrescription
DILTIAZEM HYDROCHLORIDE 180MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2015-08-25Labeling · Supplement 14 · standardAP
2011-01-20Labeling · Supplement 12AP
2007-04-12Manufacturing (CMC) · Supplement 7AP
2005-07-26Labeling · Supplement 6AP
2002-03-22Labeling · Supplement 4AP
2002-03-22Manufacturing (CMC) · Supplement 3AP
2000-12-19Labeling · Supplement 2AP
2000-12-19Manufacturing (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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