APPLICATION
ANDA088252
TYPE
ANDA
ORIGINAL APPROVAL
1983-09-01
LATEST ACTION
2024-06-05
ROUTE
ORAL
DOSAGE FORM
CONCENTRATE
MARKETING STATUS
Prescription
Products
DEXAMETHASONE INTENSOL · ReferencePrescription
DEXAMETHASONE 1MG/ML · CONCENTRATE · ORAL
Approval history
2024-06-05Labeling · Supplement 36 · standardAP
2024-01-05Manufacturing (CMC) · Supplement 35 · unknownAP
2005-07-27Labeling · Supplement 29AP
2001-01-11Manufacturing (CMC) · Supplement 24AP
2001-01-11Manufacturing (CMC) · Supplement 25AP
1996-08-28Manufacturing (CMC) · Supplement 22AP
1995-11-22Labeling · Supplement 21AP
1995-02-14Labeling · Supplement 20AP
1994-07-29Manufacturing (CMC) · Supplement 19AP
1994-02-08Labeling · Supplement 18AP
1991-08-02Labeling · Supplement 17AP
1990-12-31Labeling · Supplement 16AP
1990-04-05Labeling · Supplement 15AP
1989-03-31Manufacturing (CMC) · Supplement 12AP
1989-03-31Manufacturing (CMC) · Supplement 13AP
1989-01-25Bioequivalence · Supplement 10AP
1985-11-05Manufacturing (CMC) · Supplement 8AP
1985-11-05Manufacturing (CMC) · Supplement 9AP
1985-11-05Manufacturing (CMC) · Supplement 7AP
1985-05-22Manufacturing (CMC) · Supplement 6AP
1984-02-01Manufacturing (CMC) · Supplement 1AP
1983-09-01OriginalAP
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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