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FDA ANDA · ANDA070730

ORALONE

triamcinolone acetonide

Sponsor: SUN PHARMA CANADA

APPLICATION
ANDA070730
TYPE
ANDA
ORIGINAL APPROVAL
1986-10-01
LATEST ACTION
2011-01-27
ROUTE
DENTAL
DOSAGE FORM
PASTE
MARKETING STATUS
Prescription

Products

TRIAMCINOLONE ACETONIDEPrescription
TRIAMCINOLONE ACETONIDE 0.1% · PASTE · DENTAL

Approval history

2011-01-27Manufacturing (CMC) · Supplement 21AP
2006-06-08Labeling · Supplement 15AP
1996-10-22Manufacturing (CMC) · Supplement 11AP
1996-09-17Manufacturing (CMC) · Supplement 10AP
1996-05-14Manufacturing (CMC) · Supplement 8AP
1996-05-14Manufacturing (CMC) · Supplement 9AP
1994-04-26Manufacturing (CMC) · Supplement 7AP
1992-07-29Labeling · Supplement 6AP
1990-03-07Manufacturing (CMC) · Supplement 5AP
1989-02-13Manufacturing (CMC) · Supplement 4AP
1988-08-04Labeling · Supplement 1AP
1988-05-24Manufacturing (CMC) · Supplement 3AP
1988-03-24Manufacturing (CMC) · Supplement 2AP
1986-10-01OriginalAP
VIEW ON DRUGS@FDA ↗

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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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