FDA NDA · NDA019600

OXSORALEN-ULTRA

Sponsor: BAUSCH

APPLICATION

NDA019600

TYPE

NDA

ORIGINAL APPROVAL

1986-10-30

LATEST ACTION

2015-10-20

ROUTE

ORAL

DOSAGE FORM

CAPSULE

MARKETING STATUS

Prescription

Products

OXSORALEN-ULTRA · ReferencePrescription

METHOXSALEN 10MG · CAPSULE · ORAL

2015-10-20Manufacturing (CMC) · Supplement 18 · standardAP

2015-05-29Manufacturing (CMC) · Supplement 17 · standardAP

2003-03-26Labeling · Supplement 6 · standard — Label ↗AP

2003-03-26Labeling · Supplement 9 · standard — Label ↗AP

2001-11-23Manufacturing (CMC) · Supplement 10 · standardAP

2001-03-20Manufacturing (CMC) · Supplement 8 · standardAP

1999-05-07Manufacturing (CMC) · Supplement 7 · standardAP

1998-11-03Manufacturing (CMC) · Supplement 2 · standardAP

1998-04-07Manufacturing (CMC) · Supplement 5 · standardAP

1998-03-16Manufacturing (CMC) · Supplement 4 · standardAP

1997-12-08Manufacturing (CMC) · Supplement 3 · standardAP

1990-10-16Manufacturing (CMC) · Supplement 1 · standardAP

1986-10-30Type 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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