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FDA ANDA · ANDA084081

DEXAMETHASONE

Sponsor: SUN PHARM INDUSTRIES

APPLICATION
ANDA084081
TYPE
ANDA
ORIGINAL APPROVAL
1974-07-03
LATEST ACTION
2024-06-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

DEXAMETHASONEDiscontinued
DEXAMETHASONE 0.75MG · TABLET · ORAL

Approval history

2024-06-05Labeling · Supplement 49 · standardAP
1998-12-01Manufacturing (CMC) · Supplement 48AP
1994-12-23Manufacturing (CMC) · Supplement 47AP
1994-10-11Manufacturing (CMC) · Supplement 46AP
1992-05-08Labeling · Supplement 42AP
1992-04-03Manufacturing (CMC) · Supplement 45AP
1992-04-03Manufacturing (CMC) · Supplement 43AP
1991-01-16Labeling · Supplement 41AP
1990-04-05Labeling · Supplement 40AP
1987-03-20Manufacturing (CMC) · Supplement 38AP
1982-03-11Manufacturing (CMC) · Supplement 35AP
1974-07-03OriginalAP
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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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