FDA NDA · NDA017063

ISMOTIC

Sponsor: ALCON

APPLICATION

NDA017063

TYPE

NDA

ORIGINAL APPROVAL

1974-01-30

LATEST ACTION

1999-04-07

ROUTE

ORAL

DOSAGE FORM

SOLUTION

MARKETING STATUS

Discontinued

Products

ISMOTICDiscontinued

ISOSORBIDE 100GM/220ML · SOLUTION · ORAL

1999-04-07Manufacturing (CMC) · Supplement 12 · standardAP

1998-05-05Labeling · Supplement 11 · standardAP

1993-07-13Labeling · Supplement 9AP

1988-03-04Manufacturing (CMC) · Supplement 8 · standardAP

1981-04-07Manufacturing (CMC) · Supplement 7 · standardAP

1980-12-10Labeling · Supplement 6AP

1980-01-09Manufacturing (CMC) · Supplement 5 · standardAP

1978-06-12Manufacturing (CMC) · Supplement 4 · standardAP

1975-08-25Manufacturing (CMC) · Supplement 2 · standardAP

1974-01-30Type 2 - New Active Ingredient · 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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