FDA NDA · NDA014349

DELFEN

Sponsor: PERSONAL PRODS

APPLICATION

NDA014349

TYPE

NDA

ORIGINAL APPROVAL

1963-12-10

LATEST ACTION

1989-03-27

ROUTE

VAGINAL

DOSAGE FORM

AEROSOL

MARKETING STATUS

Discontinued

Products

DELFENDiscontinued

NONOXYNOL-9 12.5% · AEROSOL · VAGINAL

1989-03-27Manufacturing (CMC) · Supplement 33 · standardAP

1988-07-29Manufacturing (CMC) · Supplement 32 · standardAP

1988-03-31Manufacturing (CMC) · Supplement 31 · standardAP

1986-03-18Manufacturing (CMC) · Supplement 30 · standardAP

1984-09-18Manufacturing (CMC) · Supplement 29 · standardAP

1980-10-27Manufacturing (CMC) · Supplement 24 · standardAP

1980-05-14Manufacturing (CMC) · Supplement 26 · standardAP

1980-04-23Labeling · Supplement 25 · standardAP

1980-03-24Manufacturing (CMC) · Supplement 22 · standardAP

1980-03-06Manufacturing (CMC) · Supplement 23 · standardAP

1979-07-31Manufacturing (CMC) · Supplement 20 · standardAP

1979-07-31Manufacturing (CMC) · Supplement 19 · standardAP

1979-07-31Manufacturing (CMC) · Supplement 21 · standardAP

1978-04-17Manufacturing (CMC) · Supplement 12 · standardAP

1978-02-23Manufacturing (CMC) · Supplement 14 · standardAP

1963-12-10Type 3 - New Dosage Form · 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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