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FDA ANDA · ANDA070052

BETAMETHASONE VALERATE

Sponsor: SENORES PHARMS

APPLICATION
ANDA070052
TYPE
ANDA
ORIGINAL APPROVAL
1985-07-31
LATEST ACTION
1992-03-05
ROUTE
TOPICAL
DOSAGE FORM
LOTION
MARKETING STATUS
Prescription

Products

BETAMETHASONE VALERATEPrescription
BETAMETHASONE VALERATE EQ 0.1% BASE · LOTION · TOPICAL

Approval history

1992-03-05Labeling · Supplement 9AP
1991-09-03Manufacturing (CMC) · Supplement 10AP
1991-08-02Manufacturing (CMC) · Supplement 12AP
1991-08-02Manufacturing (CMC) · Supplement 13AP
1991-08-02Manufacturing (CMC) · Supplement 11AP
1989-10-13Labeling · Supplement 8AP
1989-02-15Manufacturing (CMC) · Supplement 7AP
1989-02-15Manufacturing (CMC) · Supplement 5AP
1989-02-15Manufacturing (CMC) · Supplement 6AP
1987-12-02Manufacturing (CMC) · Supplement 4AP
1986-10-09Manufacturing (CMC) · Supplement 2AP
1985-07-31OriginalAP
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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