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FDA ANDA · ANDA062832

NYSTATIN

Sponsor: SCIEGEN PHARMS

APPLICATION
ANDA062832
TYPE
ANDA
ORIGINAL APPROVAL
1991-12-27
LATEST ACTION
1999-02-11
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription

Products

NYSTATINPrescription
NYSTATIN 100,000 UNITS/ML · SUSPENSION · ORAL

Approval history

1999-02-11Manufacturing (CMC) · Supplement 8AP
1997-07-22Labeling · Supplement 6AP
1996-08-28Manufacturing (CMC) · Supplement 5AP
1994-11-10Manufacturing (CMC) · Supplement 4AP
1994-11-10Manufacturing (CMC) · Supplement 3AP
1993-07-20Manufacturing (CMC) · Supplement 1AP
1993-05-28Manufacturing (CMC) · Supplement 2AP
1991-12-27OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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