APPLICATION
NDA019471
TYPE
NDA
ORIGINAL APPROVAL
1989-01-23
LATEST ACTION
2003-03-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
CARDIZEM SR · ReferenceDiscontinued
DILTIAZEM HYDROCHLORIDE 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, EXTENDED RELEASE · ORAL
CARDIZEM SR · ReferenceDiscontinued
DILTIAZEM HYDROCHLORIDE 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, EXTENDED RELEASE · ORAL
CARDIZEM SR · ReferenceDiscontinued
DILTIAZEM HYDROCHLORIDE 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, EXTENDED RELEASE · ORAL
CARDIZEM SR · ReferenceDiscontinued
DILTIAZEM HYDROCHLORIDE 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2003-03-21Labeling · Supplement 29 · standardAP
2001-06-04Manufacturing (CMC) · Supplement 31 · standardAP
1999-12-06Manufacturing (CMC) · Supplement 30 · standardAP
1998-12-03Manufacturing (CMC) · Supplement 28 · standardAP
1997-11-20Manufacturing (CMC) · Supplement 27 · standardAP
1997-08-05Manufacturing (CMC) · Supplement 26 · standardAP
1996-05-28Labeling · Supplement 24 · standardAP
1996-05-16Manufacturing (CMC) · Supplement 25 · standardAP
1995-04-03Manufacturing (CMC) · Supplement 19 · standardAP
1995-03-17Manufacturing (CMC) · Supplement 23 · standardAP
1994-09-14Manufacturing (CMC) · Supplement 21 · standardAP
1994-09-14Manufacturing (CMC) · Supplement 20 · standardAP
1994-03-18Manufacturing (CMC) · Supplement 18 · standardAP
1994-03-15Manufacturing (CMC) · Supplement 17 · standardAP
1993-08-02Manufacturing (CMC) · Supplement 16 · standardAP
1993-04-01Labeling · Supplement 15 · standardAP
1992-10-22Manufacturing (CMC) · Supplement 13 · standardAP
1992-10-22Manufacturing (CMC) · Supplement 14 · standardAP
1992-07-01Labeling · Supplement 10 · standardAP
1991-06-13Labeling · Supplement 11 · standardAP
1991-05-03Manufacturing (CMC) · Supplement 6 · standardAP
1991-01-07Manufacturing (CMC) · Supplement 8 · standardAP
1990-09-14Manufacturing (CMC) · Supplement 7 · standardAP
1990-08-16Manufacturing (CMC) · Supplement 4 · standardAP
1990-07-27Manufacturing (CMC) · Supplement 5 · standardAP
1990-04-23Manufacturing (CMC) · Supplement 2 · standardAP
1989-03-08Manufacturing (CMC) · Supplement 1 · standardAP
1989-01-23Type 3 - New Dosage Form · Original · standardAP
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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