← FDA DRUG APPROVALS

FDA NDA · NDA018647

CORZIDE

Sponsor: KING PHARMS LLC

APPLICATION
NDA018647
TYPE
NDA
ORIGINAL APPROVAL
1983-05-25
LATEST ACTION
2021-05-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

CORZIDE · ReferenceDiscontinued
BENDROFLUMETHIAZIDE 5MG, NADOLOL 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
CORZIDE · ReferenceDiscontinued
BENDROFLUMETHIAZIDE 5MG, NADOLOL 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2021-05-26Labeling · Supplement 26 · standard — Label ↗AP
2013-07-15Labeling · Supplement 25 · standard — Letter ↗AP
2011-06-06Labeling · Supplement 24 · standard — Letter ↗AP
2008-08-12Labeling · Supplement 20 · standard — Letter ↗AP
2003-05-30Labeling · Supplement 16 · standard — Letter ↗AP
2002-05-07Manufacturing (CMC) · Supplement 15 · standardAP
1998-05-06Manufacturing (CMC) · Supplement 14 · standardAP
1997-08-11Manufacturing (CMC) · Supplement 13 · standardAP
1996-03-18Manufacturing (CMC) · Supplement 12 · standardAP
1993-03-04Manufacturing (CMC) · Supplement 7 · standardAP
1992-03-20Manufacturing (CMC) · Supplement 11 · standardAP
1991-03-28Manufacturing (CMC) · Supplement 10 · standardAP
1990-12-05Labeling · Supplement 9AP
1990-08-09Labeling · Supplement 8AP
1989-03-22Manufacturing (CMC) · Supplement 6 · standardAP
1987-01-06Manufacturing (CMC) · Supplement 5 · standardAP
1985-10-22Labeling · Supplement 4AP
1985-04-25Manufacturing (CMC) · Supplement 3 · standardAP
1984-03-06Manufacturing (CMC) · Supplement 2 · standardAP
1984-03-06Manufacturing (CMC) · Supplement 1 · standardAP
1983-05-25Type 4 - New Combination · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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