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FDA ANDA · ANDA072041

BETAMETHASONE VALERATE

Sponsor: SUN PHARMA CANADA

APPLICATION
ANDA072041
TYPE
ANDA
ORIGINAL APPROVAL
1988-01-06
LATEST ACTION
2017-03-22
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

DERMABETPrescription
BETAMETHASONE VALERATE EQ 0.1% BASE · CREAM · TOPICAL

Approval history

2017-03-22Labeling · Supplement 23 · standardAP
2004-09-27Labeling · Supplement 11AP
2001-07-11Manufacturing (CMC) · Supplement 8AP
2000-10-23Manufacturing (CMC) · Supplement 5AP
1999-04-08Manufacturing (CMC) · Supplement 7AP
1998-10-20Manufacturing (CMC) · Supplement 6AP
1996-09-17Manufacturing (CMC) · Supplement 4AP
1996-05-14Manufacturing (CMC) · Supplement 3AP
1989-03-24Manufacturing (CMC) · Supplement 2AP
1988-12-09Manufacturing (CMC) · Supplement 1AP
1988-01-06OriginalAP
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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