APPLICATION
ANDA085796
TYPE
ANDA
ORIGINAL APPROVAL
1978-11-22
LATEST ACTION
1989-02-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
NITROFURANTOINDiscontinued
NITROFURANTOIN 100MG · TABLET · ORAL
Approval history
1989-02-08Labeling · Supplement 11AP
1986-03-18Manufacturing (CMC) · Supplement 9AP
1983-05-06Manufacturing (CMC) · Supplement 6AP
1982-05-25Manufacturing (CMC) · Supplement 4AP
1981-10-22Manufacturing (CMC) · Supplement 5AP
1978-11-22OriginalAP
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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