FDA NDA · NDA019638

ARDUAN

Sponsor: ORGANON USA INC

APPLICATION

NDA019638

TYPE

NDA

ORIGINAL APPROVAL

1990-06-26

LATEST ACTION

2010-11-22

ROUTE

INJECTION

DOSAGE FORM

INJECTABLE

MARKETING STATUS

Discontinued

Products

ARDUANDiscontinued

PIPECURONIUM BROMIDE 10MG/VIAL · INJECTABLE · INJECTION

2010-11-22Labeling · Supplement 5 · standard — Letter ↗AP

1995-05-05Manufacturing (CMC) · Supplement 4 · standardAP

1994-02-28Manufacturing (CMC) · Supplement 3 · standardAP

1993-03-18Manufacturing (CMC) · Supplement 2 · standardAP

1991-12-24Labeling · Supplement 1 · standardAP

1990-06-26Type 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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