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FDA ANDA · ANDA063305

NYSTATIN AND TRIAMCINOLONE ACETONIDE

Sponsor: SUN PHARMA CANADA

APPLICATION
ANDA063305
TYPE
ANDA
ORIGINAL APPROVAL
1993-03-29
LATEST ACTION
2001-07-05
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Prescription

Products

NYSTATIN AND TRIAMCINOLONE ACETONIDEPrescription
NYSTATIN 100,000 UNITS/GM, TRIAMCINOLONE ACETONIDE 0.1% · OINTMENT · TOPICAL

Approval history

2001-07-05Manufacturing (CMC) · Supplement 9AP
1997-02-11Manufacturing (CMC) · Supplement 7AP
1997-02-10Manufacturing (CMC) · Supplement 8AP
1996-09-17Manufacturing (CMC) · Supplement 6AP
1996-04-30Labeling · Supplement 5AP
1996-04-30Manufacturing (CMC) · Supplement 3AP
1996-04-30Manufacturing (CMC) · Supplement 2AP
1995-08-24Manufacturing (CMC) · Supplement 4AP
1993-08-19Manufacturing (CMC) · Supplement 1AP
1993-03-29OriginalAP
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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