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FDA ANDA · ANDA062840

NYSTATIN

Sponsor: ACTAVIS MID ATLANTIC

APPLICATION
ANDA062840
TYPE
ANDA
ORIGINAL APPROVAL
1987-11-13
LATEST ACTION
2001-05-30
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Prescription

Products

NYSTATINPrescription
NYSTATIN 100,000 UNITS/GM · OINTMENT · TOPICAL

Approval history

2001-05-30Manufacturing (CMC) · Supplement 11AP
2000-01-18Manufacturing (CMC) · Supplement 10AP
1998-06-01Manufacturing (CMC) · Supplement 8AP
1995-10-25Manufacturing (CMC) · Supplement 6AP
1995-10-25Manufacturing (CMC) · Supplement 7AP
1995-06-19Manufacturing (CMC) · Supplement 5AP
1994-10-11Manufacturing (CMC) · Supplement 4AP
1992-05-29Manufacturing (CMC) · Supplement 3AP
1988-05-09Manufacturing (CMC) · Supplement 2AP
1987-11-13OriginalAP
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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