APPLICATION
ANDA072781
TYPE
ANDA
ORIGINAL APPROVAL
1993-07-30
LATEST ACTION
2009-09-02
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
NIFEDIPINEPrescription
NIFEDIPINE 10MG · CAPSULE · ORAL
Approval history
2009-09-02Labeling · Supplement 11AP
1994-12-09Manufacturing (CMC) · Supplement 6AP
1994-12-09Labeling · Supplement 7AP
1993-07-30OriginalAP
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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