APPLICATION
NDA050461
TYPE
NDA
ORIGINAL APPROVAL
1973-10-04
LATEST ACTION
2005-01-06
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ANCEF · ReferenceDiscontinued
CEFAZOLIN SODIUM EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
ANCEF · ReferenceDiscontinued
CEFAZOLIN SODIUM EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
ANCEF · ReferenceDiscontinued
CEFAZOLIN SODIUM EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
ANCEF · ReferenceDiscontinued
CEFAZOLIN SODIUM EQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
ANCEF · ReferenceDiscontinued
CEFAZOLIN SODIUM EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2002-05-21Manufacturing (CMC) · Supplement 134AP
1999-07-29Labeling · Supplement 133 · standardAP
1994-01-04Manufacturing (CMC) · Supplement 132AP
1992-07-14Labeling · Supplement 130AP
1992-06-22Manufacturing (CMC) · Supplement 50AP
1992-05-29Manufacturing (CMC) · Supplement 129AP
1992-03-12Manufacturing (CMC) · Supplement 45AP
1992-01-28Manufacturing (CMC) · Supplement 44AP
1991-06-28Manufacturing (CMC) · Supplement 48AP
1990-02-14Manufacturing (CMC) · Supplement 43AP
1982-09-20Labeling · Supplement 128AP
1982-07-12Labeling · Supplement 126AP
1982-07-12Labeling · Supplement 127AP
1982-06-28Labeling · Supplement 125AP
1982-06-04Labeling · Supplement 124AP
1982-05-18Labeling · Supplement 123AP
1982-05-12Labeling · Supplement 122AP
1982-05-05Labeling · Supplement 121AP
1982-04-20Labeling · Supplement 120AP
1982-03-08Labeling · Supplement 119AP
1982-02-19Labeling · Supplement 118AP
1982-01-04Labeling · Supplement 117AP
1981-11-27Manufacturing (CMC) · Supplement 116AP
1981-09-03Labeling · Supplement 115AP
1981-09-01Labeling · Supplement 114AP
1981-08-11Labeling · Supplement 113AP
1981-07-23Labeling · Supplement 112AP
1981-06-19Labeling · Supplement 109AP
1981-06-10Labeling · Supplement 111AP
1981-04-08Labeling · Supplement 110AP
1981-03-12Labeling · Supplement 108AP
1981-02-11Labeling · Supplement 107AP
1981-01-27Labeling · Supplement 106AP
1980-07-17Labeling · Supplement 105AP
1980-03-05Manufacturing (CMC) · Supplement 104AP
1980-02-26Labeling · Supplement 103AP
1979-05-15Manufacturing (CMC) · Supplement 101AP
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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