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FDA NDA · NDA017766

NEPHRAMINE 5.4%

Sponsor: B BRAUN

APPLICATION
NDA017766
TYPE
NDA
ORIGINAL APPROVAL
1978-02-24
LATEST ACTION
2014-08-27
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

NEPHRAMINE 5.4%Discontinued
AMINO ACIDS 5.4% (5.4GM/100ML) · INJECTABLE · INJECTION

Approval history

2014-08-27Manufacturing (CMC) · Supplement 41 · standardAP
2013-03-19Manufacturing (CMC) · Supplement 36 · standardAP
2006-05-04Labeling · Supplement 30 · standard — Letter ↗AP
2004-05-05Manufacturing (CMC) · Supplement 29 · standard — Label ↗AP
2002-06-12Labeling · Supplement 28 · standard — Letter ↗AP
1996-06-14Manufacturing (CMC) · Supplement 27 · standardAP
1994-10-28Manufacturing (CMC) · Supplement 26 · standardAP
1993-06-08Manufacturing (CMC) · Supplement 25 · standardAP
1992-09-28Manufacturing (CMC) · Supplement 24 · standardAP
1991-12-18Manufacturing (CMC) · Supplement 22 · standardAP
1991-12-11Manufacturing (CMC) · Supplement 23 · standardAP
1990-04-11Manufacturing (CMC) · Supplement 21 · standardAP
1988-04-11Manufacturing (CMC) · Supplement 11 · standardAP
1988-04-11Labeling · Supplement 12AP
1988-01-13Labeling · Supplement 18AP
1987-07-09Labeling · Supplement 17AP
1986-10-09Labeling · Supplement 16AP
1985-09-10Labeling · Supplement 15AP
1985-06-14Manufacturing (CMC) · Supplement 13 · standardAP
1985-04-23Labeling · Supplement 14AP
1982-10-08Labeling · Supplement 9AP
1982-06-17Manufacturing (CMC) · Supplement 8 · standardAP
1982-05-18Manufacturing (CMC) · Supplement 10 · standardAP
1981-05-04Manufacturing (CMC) · Supplement 7 · standardAP
1980-12-10Manufacturing (CMC) · Supplement 6 · standardAP
1979-08-31Manufacturing (CMC) · Supplement 4 · standardAP
1979-08-31Labeling · Supplement 5AP
1979-01-05Manufacturing (CMC) · Supplement 3 · standardAP
1979-01-04Manufacturing (CMC) · Supplement 2 · standardAP
1978-07-11Labeling · Supplement 1AP
1978-02-24Type 5 - New Formulation or New Manufacturer · 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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