APPLICATION
NDA020312
TYPE
NDA
ORIGINAL APPROVAL
1995-04-19
LATEST ACTION
2012-09-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
UNIVASCDiscontinued
MOEXIPRIL HYDROCHLORIDE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
UNIVASCDiscontinued
MOEXIPRIL HYDROCHLORIDE 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2002-12-09Manufacturing (CMC) · Supplement 19 · standardAP
2001-10-02Manufacturing (CMC) · Supplement 18 · standardAP
2001-09-24Manufacturing (CMC) · Supplement 17 · standardAP
2001-03-28Manufacturing (CMC) · Supplement 15 · standardAP
2000-07-18Manufacturing (CMC) · Supplement 13 · standardAP
2000-02-02Labeling · Supplement 14 · standardAP
1999-10-29Manufacturing (CMC) · Supplement 12 · standardAP
1999-02-11Manufacturing (CMC) · Supplement 11 · standardAP
1998-09-03Manufacturing (CMC) · Supplement 9 · standardAP
1998-04-08Labeling · Supplement 10 · standardAP
1996-11-08Manufacturing (CMC) · Supplement 8 · standardAP
1996-09-03Manufacturing (CMC) · Supplement 7 · standardAP
1996-07-09Manufacturing (CMC) · Supplement 6 · standardAP
1996-01-17Manufacturing (CMC) · Supplement 5 · standardAP
1995-10-18Manufacturing (CMC) · Supplement 1 · standardAP
1995-10-18Manufacturing (CMC) · Supplement 4 · standardAP
1995-10-18Manufacturing (CMC) · Supplement 2 · 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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