FDA NDA · NDA017601

OPTIMINE

Sponsor: SCHERING

APPLICATION

NDA017601

TYPE

NDA

ORIGINAL APPROVAL

1977-03-29

LATEST ACTION

2002-11-04

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Discontinued

Products

OPTIMINEDiscontinued

AZATADINE MALEATE 1MG · TABLET · ORAL

2002-11-04Labeling · Supplement 20 · standard — Letter ↗AP

2000-03-22Manufacturing (CMC) · Supplement 18 · standardAP

1992-07-01Manufacturing (CMC) · Supplement 15 · standardAP

1992-04-20Manufacturing (CMC) · Supplement 14 · standardAP

1991-03-06Manufacturing (CMC) · Supplement 9 · standardAP

1989-01-24Manufacturing (CMC) · Supplement 12 · standardAP

1988-04-06Manufacturing (CMC) · Supplement 11 · standardAP

1987-05-01Manufacturing (CMC) · Supplement 10 · standardAP

1986-07-08Manufacturing (CMC) · Supplement 8 · standardAP

1985-02-06Manufacturing (CMC) · Supplement 7 · standardAP

1982-08-25Labeling · Supplement 6 · standardAP

1980-03-28Manufacturing (CMC) · Supplement 5 · standardAP

1980-02-15Manufacturing (CMC) · Supplement 4 · standardAP

1980-01-08Labeling · Supplement 3 · standardAP

1979-07-12Manufacturing (CMC) · Supplement 2 · standardAP

1979-05-22Manufacturing (CMC) · Supplement 1 · standardAP

1977-03-29Type 1 - New Molecular Entity · Original · 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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