APPLICATION
NDA016822
TYPE
NDA
ORIGINAL APPROVAL
1971-09-24
LATEST ACTION
2014-03-12
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
FREAMINE HBC 6.9%Discontinued
AMINO ACIDS 6.9% (6.9GM/100ML) · INJECTABLE · INJECTION
FREAMINE III 8.5%Discontinued
AMINO ACIDS 8.5% (8.5GM/100ML) · INJECTABLE · INJECTION
FREAMINE II 8.5%Discontinued
AMINO ACIDS 8.5% (8.5GM/100ML) · INJECTABLE · INJECTION
FREAMINE III 8.5% W/ ELECTROLYTESDiscontinued
AMINO ACIDS 8.5%, MAGNESIUM ACETATE 110MG/100ML, PHOSPHORIC ACID 230MG/100ML, POTASSIUM ACETATE 10MG/100ML, POTASSIUM CHLORIDE 440MG/100ML, SODIUM ACETATE 690MG/100ML · INJECTABLE · INJECTION
FREAMINE III 10%Discontinued
AMINO ACIDS 10% (10GM/100ML) · INJECTABLE · INJECTION
FREAMINE III 3% W/ ELECTROLYTESDiscontinued
AMINO ACIDS 3%, MAGNESIUM ACETATE 54MG/100ML, PHOSPHORIC ACID 40MG/100ML, POTASSIUM CHLORIDE 150MG/100ML, SODIUM ACETATE 200MG/100ML, SODIUM CHLORIDE 120MG/100ML · INJECTABLE · INJECTION
FREAMINE 8.5%Discontinued
AMINO ACIDS 8.5% (8.5GM/100ML) · INJECTABLE · INJECTION
Approval history
2014-03-12Manufacturing (CMC) · Supplement 72 · priorityAP
2013-11-08Manufacturing (CMC) · Supplement 81 · priorityAP
2013-03-19Manufacturing (CMC) · Supplement 74 · priorityAP
2013-03-15Manufacturing (CMC) · Supplement 75 · priorityAP
2013-01-09Manufacturing (CMC) · Supplement 77 · priorityAP
2000-06-20Manufacturing (CMC) · Supplement 64 · priorityAP
2000-04-12Manufacturing (CMC) · Supplement 63 · priorityAP
1999-05-04Manufacturing (CMC) · Supplement 62 · priorityAP
1996-06-14Manufacturing (CMC) · Supplement 61 · priorityAP
1995-09-13Manufacturing (CMC) · Supplement 60 · priorityAP
1994-10-28Manufacturing (CMC) · Supplement 59 · priorityAP
1993-06-08Manufacturing (CMC) · Supplement 58 · priorityAP
1992-09-28Manufacturing (CMC) · Supplement 57 · priorityAP
1991-12-11Manufacturing (CMC) · Supplement 56 · priorityAP
1990-04-11Manufacturing (CMC) · Supplement 55 · priorityAP
1988-07-01Labeling · Supplement 44AP
1988-07-01Manufacturing (CMC) · Supplement 43 · priorityAP
1988-04-11Manufacturing (CMC) · Supplement 40 · priorityAP
1988-04-11Labeling · Supplement 41AP
1988-01-13Labeling · Supplement 52AP
1987-12-28Labeling · Supplement 51AP
1987-07-09Labeling · Supplement 50AP
1987-07-09Labeling · Supplement 49AP
1986-10-08Labeling · Supplement 48AP
1985-10-21Labeling · Supplement 46AP
1985-10-21Labeling · Supplement 47AP
1985-10-15Manufacturing (CMC) · Supplement 38 · priorityAP
1985-10-15Labeling · Supplement 39AP
1985-07-23Manufacturing (CMC) · Supplement 36 · priorityAP
1985-07-23Labeling · Supplement 37AP
1985-06-14Manufacturing (CMC) · Supplement 45 · priorityAP
1984-09-08Labeling · Supplement 42AP
1983-05-17Manufacturing (CMC) · Supplement 32 · priorityAP
1983-05-17Labeling · Supplement 33AP
1983-04-25Labeling · Supplement 30AP
1982-08-26Manufacturing (CMC) · Supplement 34 · priorityAP
1982-06-29Manufacturing (CMC) · Supplement 35 · priorityAP
1982-06-17Manufacturing (CMC) · Supplement 29 · priorityAP
1982-05-03Manufacturing (CMC) · Supplement 31 · priorityAP
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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