APPLICATION
NDA050320
TYPE
NDA
ORIGINAL APPROVAL
1970-06-23
LATEST ACTION
1988-12-19
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
UNIPEN · ReferenceDiscontinued
NAFCILLIN SODIUM EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
UNIPEN · ReferenceDiscontinued
NAFCILLIN SODIUM EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
UNIPEN · ReferenceDiscontinued
NAFCILLIN SODIUM EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
UNIPEN · ReferenceDiscontinued
NAFCILLIN SODIUM EQ 20GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
UNIPEN · ReferenceDiscontinued
NAFCILLIN SODIUM EQ 4GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
UNIPEN IN PLASTIC CONTAINER · ReferenceDiscontinued
NAFCILLIN SODIUM EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
1988-12-19Manufacturing (CMC) · Supplement 10AP
1988-08-31Manufacturing (CMC) · Supplement 12AP
1988-07-20Labeling · Supplement 11AP
1988-02-22Labeling · Supplement 9AP
1987-07-29Manufacturing (CMC) · Supplement 5AP
1987-07-08Labeling · Supplement 8AP
1987-04-14Manufacturing (CMC) · Supplement 7AP
1986-12-02Manufacturing (CMC) · Supplement 4AP
1985-12-03Manufacturing (CMC) · Supplement 3AP
1985-08-27Labeling · Supplement 6AP
1983-01-19Manufacturing (CMC) · Supplement 2AP
1982-12-28Labeling · Supplement 1AP
1982-08-12Labeling · Supplement 70AP
1982-05-12Labeling · Supplement 69AP
1981-06-01Labeling · Supplement 68AP
1981-06-01Manufacturing (CMC) · Supplement 67AP
1981-04-08Labeling · Supplement 66AP
1981-04-08Manufacturing (CMC) · Supplement 65AP
1980-11-21Labeling · Supplement 64AP
1980-08-20Manufacturing (CMC) · Supplement 63AP
1979-07-30Labeling · Supplement 62AP
1979-02-23Labeling · Supplement 61AP
1979-02-23Labeling · Supplement 60AP
1978-12-21Manufacturing (CMC) · Supplement 58AP
1978-12-21Labeling · Supplement 59AP
1978-04-28Labeling · Supplement 57AP
1978-02-06Labeling · Supplement 56AP
1978-01-19Manufacturing (CMC) · Supplement 53AP
1978-01-19Manufacturing (CMC) · Supplement 52AP
1977-12-22Labeling · Supplement 55AP
1977-10-04Labeling · Supplement 54AP
1977-08-10Labeling · Supplement 51AP
1977-06-20Manufacturing (CMC) · Supplement 47AP
1977-06-01Manufacturing (CMC) · Supplement 50AP
1977-02-11Labeling · Supplement 49AP
1977-01-11Labeling · Supplement 45AP
1977-01-11Labeling · Supplement 46AP
1976-09-23Labeling · Supplement 44AP
1976-09-07Labeling · Supplement 43AP
1976-09-07Manufacturing (CMC) · Supplement 42AP
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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