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FDA NDA · NDA020286

MONOPRIL-HCT

Sponsor: BRISTOL MYERS SQUIBB

APPLICATION
NDA020286
TYPE
NDA
ORIGINAL APPROVAL
1994-11-30
LATEST ACTION
2009-02-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

MONOPRIL-HCT · ReferenceDiscontinued
FOSINOPRIL SODIUM 10MG, HYDROCHLOROTHIAZIDE 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
MONOPRIL-HCT · ReferenceDiscontinued
FOSINOPRIL SODIUM 20MG, HYDROCHLOROTHIAZIDE 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2009-02-09Labeling · Supplement 8 · standard — Letter ↗AP
2003-10-29Labeling · Supplement 6 · standard — Letter ↗AP
2001-02-16Labeling · Supplement 4 · standardAP
2000-03-24Manufacturing (CMC) · Supplement 5 · standardAP
1997-05-20Manufacturing (CMC) · Supplement 3 · standardAP
1996-07-24Labeling · Supplement 2 · standardAP
1995-03-03Manufacturing (CMC) · Supplement 1 · standardAP
1994-11-30Type 4 - New Combination · Original · standardAP
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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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