APPLICATION
NDA017561
TYPE
NDA
ORIGINAL APPROVAL
1974-12-31
LATEST ACTION
2003-06-27
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
CELESTONE · ReferenceDiscontinued
BETAMETHASONE SODIUM PHOSPHATE EQ 3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2003-05-19Labeling · Supplement 19 · standardAP
1999-07-15Manufacturing (CMC) · Supplement 18 · standardAP
1999-02-10Manufacturing (CMC) · Supplement 17 · standardAP
1998-06-11Manufacturing (CMC) · Supplement 16 · standardAP
1997-07-21Manufacturing (CMC) · Supplement 15 · standardAP
1996-11-13Manufacturing (CMC) · Supplement 14 · standardAP
1994-04-13Labeling · Supplement 12 · standardAP
1994-03-14Manufacturing (CMC) · Supplement 11 · standardAP
1993-09-07Labeling · Supplement 10 · standardAP
1992-12-17Labeling · Supplement 9 · standardAP
1992-02-06Manufacturing (CMC) · Supplement 8 · standardAP
1987-07-23Manufacturing (CMC) · Supplement 5 · standardAP
1987-07-01Manufacturing (CMC) · Supplement 7 · standardAP
1987-04-02Manufacturing (CMC) · Supplement 6 · standardAP
1985-01-07Manufacturing (CMC) · Supplement 4 · standardAP
1982-06-30Manufacturing (CMC) · Supplement 3 · standardAP
1978-07-14Labeling · Supplement 1 · standardAP
1974-12-31Type 3 - New Dosage Form · 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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