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FDA ANDA · ANDA072651

NIFEDIPINE

Sponsor: TEVA

APPLICATION
ANDA072651
TYPE
ANDA
ORIGINAL APPROVAL
1992-02-19
LATEST ACTION
2000-01-19
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

NIFEDIPINEDiscontinued
NIFEDIPINE 10MG · CAPSULE · ORAL

Approval history

2000-01-19Manufacturing (CMC) · Supplement 17AP
1998-06-12Labeling · Supplement 16AP
1997-12-22Manufacturing (CMC) · Supplement 15AP
1996-11-14Labeling · Supplement 14AP
1996-05-16Labeling · Supplement 13AP
1994-05-24Labeling · Supplement 11AP
1994-04-21Manufacturing (CMC) · Supplement 12AP
1993-11-10Manufacturing (CMC) · Supplement 10AP
1993-11-10Labeling · Supplement 9AP
1993-11-10Manufacturing (CMC) · Supplement 7AP
1993-11-10Manufacturing (CMC) · Supplement 8AP
1993-01-04Manufacturing (CMC) · Supplement 4AP
1993-01-04Manufacturing (CMC) · Supplement 5AP
1993-01-04Labeling · Supplement 3AP
1992-12-14Manufacturing (CMC) · Supplement 6AP
1992-04-16Manufacturing (CMC) · Supplement 2AP
1992-04-16Manufacturing (CMC) · Supplement 1AP
1992-02-19OriginalAP
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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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