FDA NDA · NDA018066

UNISOM

Sponsor: CHATTEM

APPLICATION

NDA018066

TYPE

NDA

ORIGINAL APPROVAL

1978-10-18

LATEST ACTION

2022-12-01

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Over-the-counter

Products

UNISOM · ReferenceOver-the-counter

DOXYLAMINE SUCCINATE 25MG · TABLET · ORAL

2022-12-01Labeling · Supplement 21 · standard — Letter ↗AP

2013-09-12Labeling · Supplement 20 · standard — Letter ↗AP

2002-12-20Manufacturing (CMC) · Supplement 14 · standardAP

2002-05-30Labeling · Supplement 13 · standard — Letter ↗AP

2002-05-30Labeling · Supplement 11 · standard — Letter ↗AP

2002-04-26Manufacturing (CMC) · Supplement 12 · standardAP

1989-05-30Manufacturing (CMC) · Supplement 9 · standardAP

1987-08-12Manufacturing (CMC) · Supplement 6 · standardAP

1984-08-24Manufacturing (CMC) · Supplement 10 · standardAP

1984-02-23Manufacturing (CMC) · Supplement 8 · standardAP

1983-03-11Manufacturing (CMC) · Supplement 7 · standardAP

1982-08-05Manufacturing (CMC) · Supplement 4 · standardAP

1982-08-05Manufacturing (CMC) · Supplement 5 · standardAP

1981-12-21Manufacturing (CMC) · Supplement 3 · standardAP

1981-08-31Manufacturing (CMC) · Supplement 2 · standardAP

1978-10-18Type 5 - New Formulation or New Manufacturer · Original · standardAP

1978-02-13Manufacturing (CMC) · Supplement 1 · 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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