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FDA NDA · NDA005619

AMINOHIPPURATE SODIUM

Sponsor: MERCK

APPLICATION
NDA005619
TYPE
NDA
ORIGINAL APPROVAL
1944-12-30
LATEST ACTION
2013-10-24
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

AMINOHIPPURATE SODIUMDiscontinued
AMINOHIPPURATE SODIUM 20% · INJECTABLE · INJECTION

Approval history

2013-10-24Manufacturing (CMC) · Supplement 24AP
2013-06-07Manufacturing (CMC) · Supplement 23AP
2011-03-18Labeling · Supplement 21 · unknown — Letter ↗AP
2005-06-03Labeling · Supplement 20 · standard — Letter ↗AP
2002-11-26Labeling · Supplement 18 · standard — Letter ↗AP
2002-10-08Manufacturing (CMC) · Supplement 17AP
2001-03-30Manufacturing (CMC) · Supplement 16 — Letter ↗AP
1999-11-02Labeling · Supplement 15 · standardAP
1998-01-05Manufacturing (CMC) · Supplement 14AP
1996-03-11Manufacturing (CMC) · Supplement 13AP
1987-02-13Labeling · Supplement 12AP
1987-02-13Labeling · Supplement 10AP
1987-02-13Manufacturing (CMC) · Supplement 9AP
1982-09-01Manufacturing (CMC) · Supplement 11AP
1981-10-08Manufacturing (CMC) · Supplement 7AP
1981-06-23Manufacturing (CMC) · Supplement 8AP
1977-04-07Labeling · Supplement 6AP
1973-08-10Labeling · Supplement 1AP
1973-08-10Manufacturing (CMC) · Supplement 2AP
1944-12-30UNKNOWN · Original · unknownAP
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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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