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FDA ANDA · ANDA071383

ORALONE

Sponsor: SUN PHARMA CANADA

APPLICATION
ANDA071383
TYPE
ANDA
ORIGINAL APPROVAL
1987-07-06
LATEST ACTION
1992-08-13
ROUTE
DENTAL
DOSAGE FORM
PASTE
MARKETING STATUS
Discontinued

Products

ORALONEDiscontinued
TRIAMCINOLONE ACETONIDE 0.1% · PASTE · DENTAL

Approval history

1992-08-13Labeling · Supplement 6AP
1990-03-09Manufacturing (CMC) · Supplement 4AP
1988-12-28Labeling · Supplement 2AP
1987-07-06OriginalAP
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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