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FDA ANDA · ANDA075633

CLOBETASOL PROPIONATE

Sponsor: SUN PHARMA CANADA

APPLICATION
ANDA075633
TYPE
ANDA
ORIGINAL APPROVAL
2000-05-17
LATEST ACTION
2019-11-14
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

CLOBETASOL PROPIONATE (EMOLLIENT)Prescription
CLOBETASOL PROPIONATE 0.05% · CREAM · TOPICAL

Approval history

2019-11-14Labeling · Supplement 10 · standardAP
2001-10-02Manufacturing (CMC) · Supplement 2AP
2001-01-24Manufacturing (CMC) · Supplement 1AP
2000-05-17OriginalReviewAP
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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