APPLICATION
ANDA085738
TYPE
ANDA
ORIGINAL APPROVAL
1979-01-30
LATEST ACTION
1999-02-19
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
BETAMETHASONE SODIUM PHOSPHATEDiscontinued
BETAMETHASONE SODIUM PHOSPHATE EQ 3MG BASE/ML · INJECTABLE · INJECTION
Approval history
1999-02-19Manufacturing (CMC) · Supplement 23AP
1999-02-02Manufacturing (CMC) · Supplement 22AP
1996-12-04Manufacturing (CMC) · Supplement 20AP
1996-04-30Labeling · Supplement 19AP
1995-05-17Manufacturing (CMC) · Supplement 18AP
1992-08-18Manufacturing (CMC) · Supplement 15AP
1992-08-18Manufacturing (CMC) · Supplement 16AP
1988-10-21Manufacturing (CMC) · Supplement 13AP
1988-10-21Manufacturing (CMC) · Supplement 11AP
1988-10-21Manufacturing (CMC) · Supplement 12AP
1986-08-19Manufacturing (CMC) · Supplement 7AP
1982-09-13Manufacturing (CMC) · Supplement 5AP
1982-03-22Manufacturing (CMC) · Supplement 4AP
1979-01-30OriginalAP
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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