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FDA NDA · NDA050299

NYSTATIN

Sponsor: CHARTWELL MOLECULES

APPLICATION
NDA050299
TYPE
NDA
ORIGINAL APPROVAL
1971-04-14
LATEST ACTION
1999-09-23
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription

Products

NILSTAT · ReferencePrescription
NYSTATIN 100,000 UNITS/ML · SUSPENSION · ORAL

Approval history

1999-09-23Manufacturing (CMC) · Supplement 22AP
1998-05-18Manufacturing (CMC) · Supplement 21AP
1995-07-28Manufacturing (CMC) · Supplement 18AP
1995-07-28Manufacturing (CMC) · Supplement 19AP
1995-02-16Manufacturing (CMC) · Supplement 17AP
1984-07-25Manufacturing (CMC) · Supplement 4AP
1984-07-02Manufacturing (CMC) · Supplement 3AP
1983-10-14Manufacturing (CMC) · Supplement 2AP
1983-07-13Manufacturing (CMC) · Supplement 1AP
1982-09-01Manufacturing (CMC) · Supplement 16AP
1980-02-05Manufacturing (CMC) · Supplement 15AP
1978-09-25Manufacturing (CMC) · Supplement 14AP
1978-09-21Manufacturing (CMC) · Supplement 13AP
1977-01-11Manufacturing (CMC) · Supplement 12AP
1974-12-23Manufacturing (CMC) · Supplement 11AP
1974-07-22Manufacturing (CMC) · Supplement 10AP
1974-02-22Manufacturing (CMC) · Supplement 7AP
1974-02-15Labeling · Supplement 9AP
1974-02-11Manufacturing (CMC) · Supplement 8AP
1972-10-17Manufacturing (CMC) · Supplement 6AP
1972-09-28Manufacturing (CMC) · Supplement 5AP
1971-04-14UNKNOWN · Original · unknownAP
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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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