APPLICATION
NDA019915
TYPE
NDA
ORIGINAL APPROVAL
1991-05-16
LATEST ACTION
2009-02-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
MONOPRIL · ReferenceDiscontinued
FOSINOPRIL SODIUM 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
MONOPRIL · ReferenceDiscontinued
FOSINOPRIL SODIUM 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
MONOPRIL · ReferenceDiscontinued
FOSINOPRIL SODIUM 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2000-09-21Manufacturing (CMC) · Supplement 34 · standardAP
2000-06-26Manufacturing (CMC) · Supplement 33 · standardAP
1999-11-16Manufacturing (CMC) · Supplement 31 · standardAP
1999-05-24Manufacturing (CMC) · Supplement 30 · standardAP
1999-05-21Manufacturing (CMC) · Supplement 29 · standardAP
1999-03-11Manufacturing (CMC) · Supplement 28 · standardAP
1998-08-11Manufacturing (CMC) · Supplement 27 · standardAP
1998-01-28Manufacturing (CMC) · Supplement 26 · standardAP
1997-10-01Manufacturing (CMC) · Supplement 25 · standardAP
1997-09-12Manufacturing (CMC) · Supplement 24 · standardAP
1997-02-21Manufacturing (CMC) · Supplement 23 · standardAP
1997-01-14Manufacturing (CMC) · Supplement 22 · standardAP
1997-01-08Labeling · Supplement 21 · standardAP
1996-08-02Manufacturing (CMC) · Supplement 20 · standardAP
1996-07-24Labeling · Supplement 17 · standardAP
1996-03-20Manufacturing (CMC) · Supplement 19 · standardAP
1995-09-29Manufacturing (CMC) · Supplement 18 · standardAP
1995-05-02Efficacy · Supplement 9 · standardAP
1995-03-28Manufacturing (CMC) · Supplement 13 · standardAP
1995-03-27Manufacturing (CMC) · Supplement 16 · standardAP
1995-02-08Manufacturing (CMC) · Supplement 14 · standardAP
1994-12-30Manufacturing (CMC) · Supplement 15 · standardAP
1994-12-30Manufacturing (CMC) · Supplement 12 · standardAP
1994-06-14Manufacturing (CMC) · Supplement 11 · standardAP
1994-05-19Labeling · Supplement 10 · standardAP
1993-04-05Manufacturing (CMC) · Supplement 8 · standardAP
1992-10-07Labeling · Supplement 7 · standardAP
1992-09-22Manufacturing (CMC) · Supplement 5 · standardAP
1992-07-10Manufacturing (CMC) · Supplement 6 · standardAP
1992-06-25Labeling · Supplement 4 · standardAP
1991-09-09Manufacturing (CMC) · Supplement 3 · standardAP
1991-06-27Manufacturing (CMC) · Supplement 1 · standardAP
1991-06-27Manufacturing (CMC) · Supplement 2 · standardAP
1991-05-16Type 1 - New Molecular Entity · Original · standard — Other Important Information from FDA ↗AP
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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