FDA NDA · NDA021041

DEPOCYT

Sponsor: PACIRA PHARMS INC

APPLICATION

NDA021041

TYPE

NDA

ORIGINAL APPROVAL

1999-04-01

LATEST ACTION

2017-01-26

ROUTE

INJECTION

DOSAGE FORM

INJECTABLE, LIPOSOMAL

MARKETING STATUS

Discontinued

Products

DEPOCYT · ReferenceDiscontinued

CYTARABINE 10MG/ML · INJECTABLE, LIPOSOMAL · INJECTION

2017-01-26Manufacturing (CMC) · Supplement 38 · standardAP

2015-09-18Manufacturing (CMC) · Supplement 35 · priorityAP

2015-08-04Manufacturing (CMC) · Supplement 34 · priorityAP

2015-03-16Manufacturing (CMC) · Supplement 32 · priorityAP

2014-12-23Labeling · Supplement 31 · standard — Letter ↗AP

2014-08-13Manufacturing (CMC) · Supplement 29 · priorityAP

2014-04-23Manufacturing (CMC) · Supplement 27 · priorityAP

2014-04-23Manufacturing (CMC) · Supplement 28 · priorityAP

2013-08-09Manufacturing (CMC) · Supplement 26 · priorityAP

2011-08-11Labeling · Supplement 23 · standard — Label ↗AP

2007-04-19Efficacy · Supplement 18 · unknown — Letter ↗AP

2003-10-02Labeling · Supplement 10 · standard — Letter ↗AP

2003-10-02Manufacturing (CMC) · Supplement 8 · priority — Letter ↗AP

2002-12-31Manufacturing (CMC) · Supplement 6 · priorityAP

2001-03-01Manufacturing (CMC) · Supplement 4 · priorityAP

2001-01-05Manufacturing (CMC) · Supplement 3 · priorityAP

1999-04-01Type 3 - New Dosage Form · Original · priority — Review ↗AP

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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