APPLICATION
ANDA074540
TYPE
ANDA
ORIGINAL APPROVAL
1996-10-28
LATEST ACTION
2001-11-05
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
NICARDIPINE HYDROCHLORIDEDiscontinued
NICARDIPINE HYDROCHLORIDE 20MG · CAPSULE · ORAL
NICARDIPINE HYDROCHLORIDEDiscontinued
NICARDIPINE HYDROCHLORIDE 30MG · CAPSULE · ORAL
Approval history
2001-11-05Labeling · Supplement 11AP
2001-08-30Manufacturing (CMC) · Supplement 10AP
2000-07-07Manufacturing (CMC) · Supplement 8AP
2000-02-25Labeling · Supplement 9AP
1999-10-29Manufacturing (CMC) · Supplement 6AP
1999-10-29Manufacturing (CMC) · Supplement 7AP
1998-03-09Manufacturing (CMC) · Supplement 4AP
1997-07-11Manufacturing (CMC) · Supplement 2AP
1997-07-11Manufacturing (CMC) · Supplement 3AP
1997-07-11Manufacturing (CMC) · Supplement 1AP
1996-10-28OriginalAP
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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