APPLICATION
NDA019684
TYPE
NDA
ORIGINAL APPROVAL
1989-09-06
LATEST ACTION
2021-11-09
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription, Discontinued
Products
PROCARDIA XL · ReferencePrescription
NIFEDIPINE 60MG · TABLET, EXTENDED RELEASE · ORAL
PROCARDIA XL · ReferenceDiscontinued
NIFEDIPINE 90MG · TABLET, EXTENDED RELEASE · ORAL
PROCARDIA XL · ReferencePrescription
NIFEDIPINE 30MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2014-06-05Manufacturing (CMC) · Supplement 28 · standardAP
2000-04-05Manufacturing (CMC) · Supplement 17 · standardAP
1998-08-18Manufacturing (CMC) · Supplement 15 · standardAP
1997-08-12Labeling · Supplement 14 · standardAP
1997-04-21Labeling · Supplement 13 · standardAP
1996-03-29Manufacturing (CMC) · Supplement 11 · standardAP
1995-12-26Labeling · Supplement 9 · standardAP
1994-11-30Labeling · Supplement 10 · standardAP
1994-04-04Manufacturing (CMC) · Supplement 8 · standardAP
1991-03-18Manufacturing (CMC) · Supplement 6 · standardAP
1990-09-14Labeling · Supplement 5AP
1990-05-18Manufacturing (CMC) · Supplement 4 · standardAP
1990-03-08Manufacturing (CMC) · Supplement 2 · standardAP
1990-02-09Manufacturing (CMC) · Supplement 3 · standardAP
1989-11-13Manufacturing (CMC) · Supplement 1 · standardAP
1989-09-06Type 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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