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FDA ANDA · ANDA209535

TRIAMCINOLONE ACETONIDE

Sponsor: MACLEODS PHARMS LTD

APPLICATION
ANDA209535
TYPE
ANDA
ORIGINAL APPROVAL
2018-05-18
LATEST ACTION
2022-11-08
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

TRIAMCINOLONE ACETONIDEPrescription
TRIAMCINOLONE ACETONIDE 0.5% · CREAM · TOPICAL
TRIAMCINOLONE ACETONIDEPrescription
TRIAMCINOLONE ACETONIDE 0.025% · CREAM · TOPICAL
TRIAMCINOLONE ACETONIDEPrescription
TRIAMCINOLONE ACETONIDE 0.1% · CREAM · TOPICAL

Approval history

2022-11-08Manufacturing (CMC) · Supplement 12 · unknownAP
2018-05-18UNKNOWN · Original · standardAP
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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