APPLICATION
ANDA040167
TYPE
ANDA
ORIGINAL APPROVAL
1996-09-18
LATEST ACTION
2024-04-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter
Products
DOXYLAMINE SUCCINATEOver-the-counter
DOXYLAMINE SUCCINATE 25MG · TABLET · ORAL
Approval history
2024-04-04Manufacturing (CMC) · Supplement 52 · unknownAP
2024-02-20Manufacturing (CMC) · Supplement 51 · unknownAP
2023-10-06Labeling · Supplement 50 · standardAP
2015-03-06Labeling · Supplement 43 · standardAP
2014-10-09Manufacturing (CMC) · Supplement 41AP
2009-06-02Labeling · Supplement 33AP
2008-07-14Labeling · Supplement 31AP
2002-09-10Labeling · Supplement 6AP
2001-10-04Manufacturing (CMC) · Supplement 5AP
2001-10-04Manufacturing (CMC) · Supplement 4AP
1999-01-21Manufacturing (CMC) · Supplement 3AP
1998-02-10Manufacturing (CMC) · Supplement 1AP
1998-02-10Manufacturing (CMC) · Supplement 2AP
1996-09-18OriginalAP
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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