APPLICATION
NDA050520
TYPE
NDA
ORIGINAL APPROVAL
1980-12-22
LATEST ACTION
1992-05-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
SPECTROBIDDiscontinued
BACAMPICILLIN HYDROCHLORIDE 400MG · TABLET · ORAL
SPECTROBIDDiscontinued
BACAMPICILLIN HYDROCHLORIDE 800MG · TABLET · ORAL
Approval history
1992-05-29Manufacturing (CMC) · Supplement 10 · standardAP
1983-09-12Manufacturing (CMC) · Supplement 4 · standardAP
1983-09-12Manufacturing (CMC) · Supplement 5 · standardAP
1983-02-02Labeling · Supplement 3 · standardAP
1982-12-29Manufacturing (CMC) · Supplement 2 · standardAP
1982-11-23Manufacturing (CMC) · Supplement 1 · standardAP
1982-07-27Manufacturing (CMC) · Supplement 9 · standardAP
1981-11-23Manufacturing (CMC) · Supplement 8 · standardAP
1981-10-07Manufacturing (CMC) · Supplement 7 · standardAP
1981-04-14Labeling · Supplement 6 · standardAP
1980-12-22Type 1 - New Molecular Entity · Original · 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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