← FDA DRUG APPROVALS

FDA NDA · NDA018997

LIPOSYN II 10%

Sponsor: HOSPIRA

APPLICATION
NDA018997
TYPE
NDA
ORIGINAL APPROVAL
1984-08-27
LATEST ACTION
2003-04-14
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

LIPOSYN II 10%Discontinued
SAFFLOWER OIL 5%, SOYBEAN OIL 5% (5GM/100ML) · INJECTABLE · INJECTION

Approval history

2003-04-14Manufacturing (CMC) · Supplement 26 · standard — Letter ↗AP
2001-02-15Labeling · Supplement 18AP
1997-11-17Manufacturing (CMC) · Supplement 23 · standardAP
1996-08-29Manufacturing (CMC) · Supplement 22 · standardAP
1996-08-27Manufacturing (CMC) · Supplement 20 · standardAP
1994-09-22Manufacturing (CMC) · Supplement 19 · standardAP
1991-01-04Manufacturing (CMC) · Supplement 16 · standardAP
1990-11-02Manufacturing (CMC) · Supplement 17 · standardAP
1989-10-24Manufacturing (CMC) · Supplement 15 · standardAP
1989-07-20Labeling · Supplement 14AP
1986-07-24Manufacturing (CMC) · Supplement 7 · standardAP
1986-06-06Manufacturing (CMC) · Supplement 8 · standardAP
1986-04-02Manufacturing (CMC) · Supplement 5 · standardAP
1986-04-01Labeling · Supplement 9AP
1986-02-22Manufacturing (CMC) · Supplement 10 · standardAP
1985-10-17Labeling · Supplement 2AP
1985-10-17Manufacturing (CMC) · Supplement 1 · standardAP
1985-09-12Manufacturing (CMC) · Supplement 4 · standardAP
1985-01-26Manufacturing (CMC) · Supplement 3 · standardAP
1984-08-27Type 4 - New Combination · Original · standardAP
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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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