APPLICATION
NDA018582
TYPE
NDA
ORIGINAL APPROVAL
1982-05-06
LATEST ACTION
2013-08-21
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
PROCALAMINEDiscontinued
AMINO ACIDS 3%, CALCIUM ACETATE 26MG/100ML, GLYCERIN 3GM/100ML, MAGNESIUM ACETATE 54MG/100ML, PHOSPHORIC ACID 41MG/100ML, POTASSIUM CHLORIDE 150MG/100ML, SODIUM ACETATE 200MG/100ML, SODIUM CHLORIDE 120MG/100ML · INJECTABLE · INJECTION
Approval history
2013-08-21Manufacturing (CMC) · Supplement 47 · standardAP
2013-03-19Manufacturing (CMC) · Supplement 42 · standardAP
2000-06-20Manufacturing (CMC) · Supplement 30 · standardAP
2000-04-12Manufacturing (CMC) · Supplement 29 · standardAP
1999-05-04Manufacturing (CMC) · Supplement 28 · standardAP
1996-06-14Manufacturing (CMC) · Supplement 27 · standardAP
1995-09-13Manufacturing (CMC) · Supplement 26 · standardAP
1994-10-28Manufacturing (CMC) · Supplement 24 · standardAP
1993-06-08Manufacturing (CMC) · Supplement 23 · standardAP
1992-09-28Manufacturing (CMC) · Supplement 22 · standardAP
1991-12-11Manufacturing (CMC) · Supplement 21 · standardAP
1990-04-11Manufacturing (CMC) · Supplement 20 · standardAP
1988-04-11Labeling · Supplement 9AP
1988-03-07Manufacturing (CMC) · Supplement 8 · standardAP
1987-12-08Labeling · Supplement 17AP
1987-07-09Labeling · Supplement 16AP
1986-11-13Manufacturing (CMC) · Supplement 14 · standardAP
1986-05-21Labeling · Supplement 12AP
1985-09-10Labeling · Supplement 5AP
1985-09-10Manufacturing (CMC) · Supplement 4 · standardAP
1985-06-27Manufacturing (CMC) · Supplement 6 · standardAP
1985-06-14Manufacturing (CMC) · Supplement 10 · standardAP
1982-08-26Manufacturing (CMC) · Supplement 2 · standardAP
1982-07-19Manufacturing (CMC) · Supplement 1 · standardAP
1982-07-01Manufacturing (CMC) · Supplement 3 · standardAP
1982-05-06Type 3 - New Dosage Form · 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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