APPLICATION
ANDA073250
TYPE
ANDA
ORIGINAL APPROVAL
1991-10-08
LATEST ACTION
2018-05-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
NIFEDIPINEPrescription
NIFEDIPINE 10MG · CAPSULE · ORAL
Approval history
2018-05-21Labeling · Supplement 10 · standardAP
2001-06-19Manufacturing (CMC) · Supplement 7AP
1998-12-31Manufacturing (CMC) · Supplement 6AP
1998-06-12Labeling · Supplement 5AP
1997-01-24Labeling · Supplement 4AP
1996-07-31Manufacturing (CMC) · Supplement 2AP
1996-07-26Labeling · Supplement 3AP
1992-03-24Labeling · Supplement 1AP
1991-10-08OriginalAP
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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