APPLICATION
NDA012657
TYPE
NDA
ORIGINAL APPROVAL
1961-04-17
LATEST ACTION
1998-11-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CELESTONEDiscontinued
BETAMETHASONE 0.6MG · TABLET · ORAL
Approval history
1998-11-19Manufacturing (CMC) · Supplement 25 · standardAP
1998-03-16Manufacturing (CMC) · Supplement 24 · standardAP
1997-05-07Manufacturing (CMC) · Supplement 23 · standardAP
1996-09-10Manufacturing (CMC) · Supplement 21 · standardAP
1994-08-10Manufacturing (CMC) · Supplement 19 · standardAP
1994-04-13Labeling · Supplement 20 · standardAP
1993-09-07Labeling · Supplement 18 · standardAP
1992-12-17Labeling · Supplement 17 · standardAP
1987-04-02Manufacturing (CMC) · Supplement 16 · standardAP
1986-10-20Manufacturing (CMC) · Supplement 15 · standardAP
1983-04-26Manufacturing (CMC) · Supplement 13 · standardAP
1982-11-23Manufacturing (CMC) · Supplement 14 · standardAP
1982-06-30Manufacturing (CMC) · Supplement 12 · standardAP
1981-04-11Manufacturing (CMC) · Supplement 10 · standardAP
1979-10-03Manufacturing (CMC) · Supplement 6 · standardAP
1979-07-23Manufacturing (CMC) · Supplement 7 · standardAP
1978-11-08Labeling · Supplement 5 · standardAP
1961-04-17Type 1 - New Molecular Entity · Original · standardAP
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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